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SAN FRANCISCO -- Georgetown University Medical Center autism specialists working with Latino families in Washington, DC, have developed an effective screening program that identifies Latino infants who may be at risk for autism spectrum disorder (ASD), allowing the opportunity for early intervention. Their unique model is being presented at the International Meeting for Autism Research (IMFAR) in San Francisco May 10-13. The years-long, federally-funded effort took a deep dive into Latino cultural norms in order to develop an ethnically sensitive screening methodology. In the year before their study started, very few toddlers in their target population were screened for autism risk -- less than 10 percent of Latino 18-30 month olds received screening -- and no children were identified to be at risk for ASD. At the end of the study and after incorporating the new screening model, more than 90 percent of the infants were screened during well-child doctor visits. Four percent were identified to be at possible risk and referred for more specific ASD testing. "This rate mirrors the rate of positive screens found in studies of U.S. English-language toddlers," says the study's senior investigator, Bruno Anthony, PhD, deputy director for the Georgetown University Center for Child and Human Development, and professor of pediatrics and psychiatry. "It appears that our approach is effectively picking up children that might benefit from early intervention that can improve outcomes such as cognition, peer interactions, language development and strategies to enhance families coping abilities," explains Anthony. The rate of autism, in general in the U.S., is 1 in 68, says Anthony. More than half of infants referred for further assessment from ASD screening are found not to meet criteria for ASD, he adds. The screening program was tested over 18 months at the Unity Health Care's Upper Cordozo Health Center in Washington, DC, which cares for 7,000 infants (0-3 years old) each year, 70 percent of whom are Latino. One in six of the 93,000 District of Columbia residents rely on Unity Health Care services, which treats community members regardless of their ability to pay. The typical screening tool used in the U.S. to diagnose ASD risk is the M-CHAT (the Modified Checklist for Autism in Toddlers), which is a questionnaire for parents regarding the behavior of their child. Positive answers may lead to further testing. But the M-CHAT, even when translated into Spanish, is not commonly being used with Latino parents, says Anthony. "Our prework for this study found that these parents often do not understand the questions, which can be culturally ambiguous," he says. Anthony and his group adapted the implementation of the M-CHAT for Latino population, to include explanations of some questions and oral administration by "family navigators" who were bilingual, bicultural, and who had "lived experience" of raising children diagnosed with ASD or developmental disorders. Over time, physicians and other health care workers at Upper Cardozo gradually took over the screening process from the family navigators. "We found that Latino parents were often not comfortable talking about their child's possible behavioral issues and developmental delays. We had to work hard to give them the sense that this is appropriate and safe in a medical setting," Anthony says. Information from this study allowed the Georgetown and Upper Cardozo team to articulate 10 key steps in integrating a "Supported Screening" model. Unity Health Care has now used the model to implement screening for developmental delays and mental health, according to Anthony. "We are very excited about this finding because it shows that universal screening for ASDs and developmental delays in primary care can be effective if the program is responsive to community and provider needs that inform outreach, family engagement, training, and clinical procedures," says Anthony. The study was funded by the Maternal and Child Health Bureau of the Health Resources & Services Administration (HRSA), project number R40 MC 20171-01. GGeorgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook, Twitter (@gumedcenter) and Instagram (@gumedcenter).


News Article | May 18, 2017
Site: www.sciencedaily.com

A new investigation of more than 48,000 stored tumor samples finds evidence of a key deficiency in a repair mechanism designed to keep DNA from being mutated and causing cancer. The DNA repair deficiency, called homologous recombination deficiency, or HRD, has previously been studied in only a few cancers, but as researchers at Georgetown Lombardi Comprehensive Cancer Center report, HRD can be found in all of the cancer types the researchers studied, including prostate, breast, cervical, and endometrial cancers as well as two of the more deadly types: ovarian cancer and glioma, a type of brain cancer. The researchers say the findings could play an important role in identifying which mutated genes, and which types of cancer, could be targeted to take advantage of the deficiency and ultimately help in treating the cancer. The abstract describing the work was released today. Additional details will be presented at the American Society of Clinical Oncology annual meeting next month in Chicago. "We know that patients with BRCA mutations are at high risk for developing breast, as well as pancreatic, ovarian, prostate and other cancers, and we have learned over time that BRCA plays a very important role in DNA damage repair. But BRCA is just one of the many genes that encode important proteins in the DNA repair pathway known as homologous recombination," says the study's lead author, Arielle Heeke, MD, a clinical fellow at Georgetown Lombardi Comprehensive Cancer Center. "With ongoing studies of the homologous recombination pathway and its impact on cancer development, we may identify additional genes that, when mutated, allow for either improved response to specific treatments or conversely, portend more aggressive tumor biology, and this could greatly inform development of new cancer therapies," Heeke explains. In this study, Lombardi researchers partnered with Caris Life Sciences, Inc. Caris performed the molecular profiling on 48,733 solid tumor samples to assess the prevalence of homologous recombination deficiency in about 20 different types of solid tumors. The investigators identified evidence of HRD-related mutations in 11.61 percent of them, with the highest concentration of mutations in endometrial cancer, gliomas, and ovarian cancers (38, 15 and 12 percent respectively). The most commonly mutated genes were found to be the ATM, PTEN, BRCA2, BRCA1, and ATRX genes. "We do not yet know the clinical impact of many of these mutations. However, several clinical trials are currently underway to assess a type of therapy that inhibits a DNA repair enzyme known as PARP in tumors with HRD," said Heeke. "In fact, Lombardi has a clinical trial that will open this summer evaluating the use of a PARP inhibitor in patients with tumors with this key deficiency." Heeke says the study would be open to people whose tumors have evidence of HRD like those found in this study, which includes bladder, breast, cervix, liver and bile duct, colorectal, endometrial, gastric/esophageal, head & neck, kidney, neuroendocrine, lung, ovarian, pancreas, prostate, sarcoma, and thyroid cancers, as well as gastrointestinal stromal tumors, glioma, melanoma and unknown primary cancers. The trial "Niraparib Plus Carboplatin in Patients with Homologous Recombination Deficient Advanced Solid Tumor Malignancies" is not yet recruiting patients for enrollment. "If, as we postulate, the combination of chemotherapy and PARP inhibition is successful in treating patients with HRD tumors, I expect that others will start exploring whether similar drugs or analogous therapies can make a difference in these diseases," Heeke concludes.


News Article | May 17, 2017
Site: www.eurekalert.org

WASHINGTON (May 17, 2017) -- A new investigation of more than 48,000 stored tumor samples finds evidence of a key deficiency in a repair mechanism designed to keep DNA from being mutated and causing cancer. The DNA repair deficiency, called homologous recombination deficiency, or HRD, has previously been studied in only a few cancers, but as researchers at Georgetown Lombardi Comprehensive Cancer Center report, HRD can be found in all of the cancer types the researchers studied, including prostate, breast, cervical, and endometrial cancers as well as two of the more deadly types: ovarian cancer and glioma, a type of brain cancer. The researchers say the findings could play an important role in identifying which mutated genes, and which types of cancer, could be targeted to take advantage of the deficiency and ultimately help in treating the cancer. The abstract describing the work was released today. Additional details will be presented at the American Society of Clinical Oncology annual meeting next month in Chicago. "We know that patients with BRCA mutations are at high risk for developing breast, as well as pancreatic, ovarian, prostate and other cancers, and we have learned over time that BRCA plays a very important role in DNA damage repair. But BRCA is just one of the many genes that encode important proteins in the DNA repair pathway known as homologous recombination," says the study's lead author, Arielle Heeke, MD, a clinical fellow at Georgetown Lombardi Comprehensive Cancer Center. "With ongoing studies of the homologous recombination pathway and its impact on cancer development, we may identify additional genes that, when mutated, allow for either improved response to specific treatments or conversely, portend more aggressive tumor biology, and this could greatly inform development of new cancer therapies," Heeke explains. In this study, Lombardi researchers partnered with Caris Life Sciences, Inc. Caris performed the molecular profiling on 48,733 solid tumor samples to assess the prevalence of homologous recombination deficiency in about 20 different types of solid tumors. The investigators identified evidence of HRD-related mutations in 11.61 percent of them, with the highest concentration of mutations in endometrial cancer, gliomas, and ovarian cancers (38, 15 and 12 percent respectively). The most commonly mutated genes were found to be the ATM, PTEN, BRCA2, BRCA1, and ATRX genes. "We do not yet know the clinical impact of many of these mutations. However, several clinical trials are currently underway to assess a type of therapy that inhibits a DNA repair enzyme known as PARP in tumors with HRD," said Heeke. "In fact, Lombardi has a clinical trial that will open this summer evaluating the use of a PARP inhibitor in patients with tumors with this key deficiency." Heeke says the study would be open to people whose tumors have evidence of HRD like those found in this study, which includes bladder, breast, cervix, liver and bile duct, colorectal, endometrial, gastric/esophageal, head & neck, kidney, neuroendocrine, lung, ovarian, pancreas, prostate, sarcoma, and thyroid cancers, as well as gastrointestinal stromal tumors, glioma, melanoma and unknown primary cancers. The trial "Niraparib Plus Carboplatin in Patients with Homologous Recombination Deficient Advanced Solid Tumor Malignancies" is not yet recruiting patients for enrollment. "If, as we postulate, the combination of chemotherapy and PARP inhibition is successful in treating patients with HRD tumors, I expect that others will start exploring whether similar drugs or analogous therapies can make a difference in these diseases," Heeke concludes. Co-authors include Filipa Lynce, Michael Pishvaian, and Claudine Isaacs of Georgetown Lombardi, and Tabari Baker of Caris Life Sciences, Inc. Heeke and the other co-authors report having no personal financial interests related to the study. Caris, under the guidance of Baker, provided the tissue and ran the molecular profiling on solid tumor samples collected from across the United States. Georgetown Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute as a comprehensive cancer center -- the only cancer center of its kind in the Washington, DC area. A part of Georgetown University Medical Center and MedStar Georgetown University Hospital, Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Connect with Georgetown Lombardi on Facebook(Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer). Georgetown University Medical Center (GUMC is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC onFacebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter) and Instagram (@gumedcenter).


Receive press releases from The Children's Cancer Foundation, Inc.: By Email The Children’s Cancer Foundation, Inc. (CCF) Highlights Critical Pediatric Cancer Treatment Research at 2nd Annual Research Symposium on June 7, 2017 Columbia, MD, April 16, 2017 --( Each year in the U.S., more than 50,000 children are diagnosed with cancer, and approximately 1000 will die. While the survival rate has improved in the last thirty years, cancer treatment for children is decades behind their adult counterparts. This disparity is primarily a result of the lack of interest from pharmaceutical firms for a variety of reasons including fewer patients and regulatory issues that limit future profits. Most impacted families find this outlook unacceptable, and quickly learn how important it is for the government to provide research funding, specifically to treat and cure pediatric cancer. However, of the current U.S. federal government cancer research budget, managed through the National Institutes of Health, only 4% is allocated for pediatric cancer research. Further, given the recent proposed U.S. budget from the White House, this 4% is widely considered in jeopardy. The Children’s Cancer Foundation, Inc. recognizes the necessity of innovative pediatric cancer research, and, with its Scientific Advisory Board, will hold its 2nd Annual CCF Research Symposium on June 7th. This free, day-long event, entitled “New Drugs for New Cures,” will highlight the latest activity in treatment for cancers such as sarcomas, embryonal tumors, brain cancers, and leukemia. A dozen leading pediatric oncology researchers will discuss the advancements of their work, while others will display poster presentations covering research efforts. The day’s keynote will be Gregory H. Reaman, M.D., Associate Director for Oncology Sciences in the Office of Hematology and Oncology in the Center for Drug Evaluation and Research at the FDA. Dr. Reaman is a leading voice for pediatric cancer research and directed the Center for Cancer and Blood Disorders at the Children’s National Medical Center for more than 17 years. “The CCF and its Scientific Advisory Board hopes that these annual symposia call attention to the remarkable work happening in the field of pediatric oncology, as well as the necessity to fund these efforts in their beginning stages,” offered Jeffrey Toretsky, M.D., Chair of the CCF Scientific Advisory Board, and Researcher at the Georgetown Lombardi Comprehensive Cancer Center. Dr. Toretsky is also a recipient of CCF research funding that began over 20 years ago, when his early work was a collection of ideas in need of financial support to generate data. “CCF’s founder, Shirley Howard, started her work in 1983 and helped transform pediatric oncology facilities into family- and child-supportive environments throughout the Baltimore-D.C. region. While CCF continues to support these facilities and the programs that support current pediatric cancer patients, we recognize the critical need to fund innovative strategies that are unique to pediatric oncology research. Those early dollars can help researchers advance their theories, and ultimately lead to more effective treatment and cures for pediatric cancer,” explains CCF Executive Director Tasha Museles. CCF anticipates more than 200 attendees, largely from the medical research community, but also advocates, families and others seeking a better understanding of the area’s latest pediatric oncology research. For the second year in a row, the symposium will be hosted in Landover at the Giant Food Headquarters, a longtime supporter of CCF. For more information and to register, please visit the CCF website at http://www.childrenscancerfoundation.org or contact the CCF offices at 443-546-4479 and info@childrenscancerfoundation.org. Founded in 1983, The Children’s Cancer Foundation, Inc. is a 501 (c)(3) non-profit organization dedicated to the treatment and cure of childhood cancer in the Maryland, D.C. and Northern Virginia region. CCF has awarded more than $36.6 million dollars to support facilities, research and programs to benefit pediatric cancer patients and their families. Columbia, MD, April 16, 2017 --( PR.com )-- The Children’s Cancer Foundation, Inc. (CCF) highlights critical pediatric cancer treatment research at 2nd Annual Research Symposium on June 7, 2017Each year in the U.S., more than 50,000 children are diagnosed with cancer, and approximately 1000 will die. While the survival rate has improved in the last thirty years, cancer treatment for children is decades behind their adult counterparts. This disparity is primarily a result of the lack of interest from pharmaceutical firms for a variety of reasons including fewer patients and regulatory issues that limit future profits.Most impacted families find this outlook unacceptable, and quickly learn how important it is for the government to provide research funding, specifically to treat and cure pediatric cancer. However, of the current U.S. federal government cancer research budget, managed through the National Institutes of Health, only 4% is allocated for pediatric cancer research. Further, given the recent proposed U.S. budget from the White House, this 4% is widely considered in jeopardy.The Children’s Cancer Foundation, Inc. recognizes the necessity of innovative pediatric cancer research, and, with its Scientific Advisory Board, will hold its 2nd Annual CCF Research Symposium on June 7th. This free, day-long event, entitled “New Drugs for New Cures,” will highlight the latest activity in treatment for cancers such as sarcomas, embryonal tumors, brain cancers, and leukemia. A dozen leading pediatric oncology researchers will discuss the advancements of their work, while others will display poster presentations covering research efforts. The day’s keynote will be Gregory H. Reaman, M.D., Associate Director for Oncology Sciences in the Office of Hematology and Oncology in the Center for Drug Evaluation and Research at the FDA. Dr. Reaman is a leading voice for pediatric cancer research and directed the Center for Cancer and Blood Disorders at the Children’s National Medical Center for more than 17 years.“The CCF and its Scientific Advisory Board hopes that these annual symposia call attention to the remarkable work happening in the field of pediatric oncology, as well as the necessity to fund these efforts in their beginning stages,” offered Jeffrey Toretsky, M.D., Chair of the CCF Scientific Advisory Board, and Researcher at the Georgetown Lombardi Comprehensive Cancer Center. Dr. Toretsky is also a recipient of CCF research funding that began over 20 years ago, when his early work was a collection of ideas in need of financial support to generate data.“CCF’s founder, Shirley Howard, started her work in 1983 and helped transform pediatric oncology facilities into family- and child-supportive environments throughout the Baltimore-D.C. region. While CCF continues to support these facilities and the programs that support current pediatric cancer patients, we recognize the critical need to fund innovative strategies that are unique to pediatric oncology research. Those early dollars can help researchers advance their theories, and ultimately lead to more effective treatment and cures for pediatric cancer,” explains CCF Executive Director Tasha Museles. CCF anticipates more than 200 attendees, largely from the medical research community, but also advocates, families and others seeking a better understanding of the area’s latest pediatric oncology research.For the second year in a row, the symposium will be hosted in Landover at the Giant Food Headquarters, a longtime supporter of CCF. For more information and to register, please visit the CCF website at http://www.childrenscancerfoundation.org or contact the CCF offices at 443-546-4479 and info@childrenscancerfoundation.org.Founded in 1983, The Children’s Cancer Foundation, Inc. is a 501 (c)(3) non-profit organization dedicated to the treatment and cure of childhood cancer in the Maryland, D.C. and Northern Virginia region. CCF has awarded more than $36.6 million dollars to support facilities, research and programs to benefit pediatric cancer patients and their families. Click here to view the list of recent Press Releases from The Children's Cancer Foundation, Inc.


News Article | June 30, 2017
Site: www.eurekalert.org

WASHINGTON (June 30, 2017) -- Based on a new molecular study of tissues biopsied from various parts of the upper digestive tract, researchers at Georgetown Lombardi Comprehensive Cancer Center have identified significant, if subtle, differences in gene mutations and other factors that could help in developing more tailored treatment options for cancer patients. This finding is notable because as the digestive tract winds its way down from the mouth to the rectum, a continuum of cancers can arise, each of which may be amenable to precision treatment. In this study, the researchers focused primarily on small bowel adenocarcinomas (SBAs) and compared them with parts of the upper digestive tract that precede it and follow it - the gastroesophageal area and right-sided colon cancers, respectively. Each section of the gastrointestinal, or GI, tract plays a role in digestion of food and hence has distinct structural as well as molecular differences. The finding will be presented June 30, 2017, at the European Society for Medical Oncology gastrointestinal meeting in Barcelona, Spain. "Our study was undertaken primarily because SBAs are greatly understudied, as well as increasing in incidence nationwide, and we wanted to determine what may make them unique," says Mohamed E. Salem, MD, assistant professor of medicine at Georgetown Lombardi, and principal investigator for the study. "We really didn't have good data on SBAs so we've been treating the tumors as if they were colon cancers and we really need to start treating them based on their unique properties." The investigators looked at 4,278 tumor samples from a tissue repository of patients with GI tract cancers. The researchers were able to clearly identify 531 SBAs; 2,674 gastroesophageal cancers; and 1,073 ride-sided colon cancers. Using a variety of genetic sequencing techniques, they ascertained how well the genes were expressed, or "turned on" to make proteins. They also calculated what is called the tumor mutational load, or TML, which can be a marker for how responsive a tumor is to immunotherapy - which, paradoxically, could indicate that immunotherapy more effective when a higher TML is found. The researchers found a set of frequently mutated genes in SBAs that could be helpful to clinicians when they are looking to use targeted therapies that work best in cancers with specifics mutations. In this case, KRAS, BRAF, BRCA2 and a few other genes were identified in SBAs. Mutations to these genes can affect the choice of therapy as well as how to better target the mutations. Next, the investigators compared the SBA mutations with mutations in the two other parts of the GI tract and found higher and lower mutation frequencies across a wide array of genes. They were able to discern that SBAs were more like colon than gastric cancers. More importantly, though, they found about a two-fold higher PD-L1 expression level for gastroesophageal cancers compared to right-side colon cancers but did not find such a marked difference between those tumors and SBAs. PD-L1 is often used as a marker to indicate if a cancer might be responsive to immunotherapy, and usually the higher the PD-L1 level, the more responsive a cancer would be to certain immunotherapies. "With this study we now have what I think is one of the biggest datasets on SBAs," says Salem. "Previously, investigators studying the colon found very unique differences between the left and ride sides, and our study therefore took advantage of those findings by exploring the differences between ride-sided colon cancers and SBAs. We now see a continuum of molecular changes that occur as these regions of the digestive tract transition from one area to the other." The next step, says Salem, will be to try to correlate these findings with patient treatment outcomes, initially as a retrospective, or backward looking study, and then hopefully design a forward looking clinical trial to determine which treatments may be best for patients with SBAs. In addition to Salem, other authors of this study include Heinz-Josef Lenz, USC Norris Comprehensive Cancer Center; Anthony Shields and Philip Philip, Karmanos Cancer Center; Joanne Xiu and Tabari Baker, Caris Life Sciences; and Jimmy Hwang and John Marshall, Lombardi Comprehensive Cancer Center, Georgetown University. The work was supported by Georgetown Lombardi's Ruesch Center for the Cure of Gastrointestinal Cancer. Salem reports having no personal financial interests related to the study. Georgetown Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute as a comprehensive cancer center -- the only cancer center of its kind in the Washington, DC area. A part of Georgetown University Medical Center and MedStar Georgetown University Hospital, Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer). Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter) and Instagram (@gumedcenter).


News Article | February 19, 2017
Site: www.eurekalert.org

WASHINGTON (Feb. 19, 2017) -- Can statistics increase the value of science to society? Georgetown University's Rochelle Tractenberg, PhD, MPH, PhD, chair of the Committee on Professional Ethics of the American Statistical Association, will discuss "Promoting Ethical Science and Policy With Ethical Statistical Practice" on a panel presenting three disciplinary perspectives on Sunday, February 19, from 8:00 am to 9:30 am as part of a day long symposium titled Scientific Reproducibility and Social Responsibility at the AAAS 2017 Annual Meeting in Boston. A survey of more than 1,500 investigators, published in a 2016 issue of Nature, showed that more than 70 percent of researchers have tried and failed to reproduce other scientists' experiments, and more than half have failed to reproduce their own experiments. Additional studies have come to similar conclusions, says Tractenberg, associate professor of neurology at Georgetown University Medical Center with secondary appointments in biostatistics, bioinformatics and biomathematics, and rehabilitation medicine. "Irreproducible results do harm that can be difficult to discover and even more difficult to undo," she said. A consulting statistician and practicing scientist for the past 20 years, Tractenberg started pursuing her interest in promoting ethical research skills in 2009 after being invited to join a GUMC task force to explore these challenges. Tractenberg has worked with colleagues at GUMC and other institutions around the country to promote this brand of responsible research, and she'll have a larger stage later this month. Tractenberg will discuss responsible research, and its relevance for all statisticians, data analysts and data scientists, in a symposium she organized for the AAAS 2017 Annual Meeting. When most investigators have taken just a single course in statistics, and are therefore laymen when it comes to statistics - for typical experiments or if they wish to participate in big data analyses - it is perhaps not surprising that so many studies cannot be replicated, nor results reproduced, Tractenberg says. "My focus on promoting ethical statistical practice arose because a scientific credibility crisis is emerging due partly to scientists who do not conduct - or insist upon - appropriate statistical analysis or interpretation, or both," she says. "If ethical statistical practice becomes the norm across statistics and data science, it may then be taken up into other domains where data analysis makes important contributions." Several elements of a study can lead to irreproducible results, including incorrect analysis, improper interpretation of data, cherry picking results, or failing to transparently report the number of analyses that were done, Tractenberg says. Avoiding these are principles of ethical statistical practice as well as responsible conduct in research. "Although it can often seem that data analysis is secondary to the 'main' science or study purpose, the analytic method and its interpretation are essential attributes of both rigor and reproducibility, and this is true for their own work and for their peer review of others' work," says Tractenberg. A large number of these irreproducible studies may have never been published if peer reviewers that were unable to evaluate the statistics "just told the editor they don't feel qualified to evaluate the study's statistical argument, and that a formal statistical review is needed," she says. Having a formal statistical review does not guarantee reproducibility or rigor, but not having or insisting on one virtually guarantees the continuation of the reproducibility crisis. A faculty member at Georgetown since 2002, Tractenberg was appointed to the national Committee on Professional Ethics of the American Statistical Association (ASA) in 2013, a committee that she now chairs. In her 90-minute panel at the AAAS meeting, "How Ethical Science Supports Ethical Policy: Disciplinary Perspectives," she will discuss the ASA Ethical Guidelines for Statistical Practice, which all those who analyze data can utilize, whether dealing with "small" or "big" data. She says that ethical statistical practice - by every data analyst - is integral to maintaining the value of science in society. Tractenberg's panel will also bring together specialists in engineering and economics to describe their efforts to establish and promote ethical practices and policies within their disciplines. These three perspectives will then be discussed with respect to their potential to influence and support ethical policy and decision making. "All scientific fields have different relationships to data and how the data should be interpreted," Tractenberg says. "But the core of all in this work is the data and its analysis, and I firmly believe these must be dealt with ethically. Otherwise, decisions that are based on these results may be incorrect or indefensible, or both." "The data analyst, whether a professional statistician or just the group member who is most skilled with the analysis software, has an obligation to treat and interpret the data ethically," Tractenberg says. "In a post-truth world, this may be the best way to promote scientific integrity." Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook, Twitter @gumedcenter and Instagram (@gumedcenter.


News Article | February 15, 2017
Site: news.yahoo.com

To eat soy or not: That's the question many U.S. women have been asking. Tofu, miso paste and other soybean-based foods are high-quality sources of protein that are low in calories and saturated fat. And studies have shown that they can help prevent cancer. Yet many doctors recommend that women who have, or are at risk of developing, a common form of breast cancer called estrogen-receptor-positive breast cancer  avoid eating soybean-based foods because they contain compounds called isoflavones. Some studies suggest that isoflavones can mimic the hormone estrogen and encourage tumor growth. Now, in an animal study, researchers at the Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C., have uncovered a possible reason for the apparent Jekyll-and-Hyde nature of soy — how it can both prevent cancer and fuel its spread. [Top 10 Cancer-Fighting Foods] The researchers found that rats that were given soybean isoflavones to eat throughout their lives — in particular, one type of soybean isoflavone called genistein — had improved immunity against cancer. But rats that weren't given the isoflavone until after developing breast cancer didn't have that same immune response to kill cancer cells. Instead, these rats had higher rates of cancer growth and higher rates of recurrence after their tumors were removed. The study may explain why women in Asian countries, who tend to consume high amounts of soybean-based foods throughout their lifetime, have rates of breast cancer that are five times lower than those of women in the United States, the researchers said. The findings were published today (Feb. 1) in the journal Clinical Cancer Research. More than 200,000 U.S. women are diagnosed each year with breast cancer, and the majority have estrogen-receptor-positive breast cancer, according to the Centers for Disease Control and Prevention. One of the most common drugs to combat this type of cancer is tamoxifen, which acts to reduce estrogen's ability to promote cancer growth. In their animal study, the researchers induced cancer growth in rats that had a steady diet of genistein and in rats that never had any genistein until after the cancer developed. All of the rats were then treated with tamoxifen to kill the cancer. The researchers found that the rats raised on genistein had only a 7 percent chance of breast cancer recurrence after tamoxifen treatment, but the rats that were recently given genistein had a 33 percent recurrence rate. It's not clear why genistein would have this effect but it may be related to the body's immune system being activated by the isoflavone, recognizing it as a nutrient from its longtime consumption, said study senior author Leena Hilakivi-Clarke, a professor of oncology at the Georgetown Lombardi Comprehensive Care Center. "The immune system was not activated in animals that started consuming genistein for the first time with tamoxifen," Hilakivi-Clarke told Live Science. This may have resulted in the genistein appearing more like the cancer-fueling estrogen and less like a tumor-fighting agent, she said. In other words, the paradox is in the timing. It may be that soy consumption is protective only if started before cancer develops. Despite the lingering ambiguity of whether the same is true in humans, Hilakivi-Clarke thinks the animal study can inform doctors and their patients. "We have solved the puzzle of genistein and breast cancer in our rat model, which perfectly explains the paradox seen in earlier animal studies and patients," Hilakivi-Clarke said. "While many oncologists advise their patients not to take isoflavone supplements or consume soy foods, our findings suggest a more nuanced message — if these results hold true for women. Our results suggest that breast cancer patients [who ate soy before their diagnosis] should continue consuming soy foods after diagnosis, but not to start them if they have not consumed genistein previously." [6 Foods That May Affect Breast Cancer Risk] Maggie Neola, a staff dietitian for the Barnard Medical Center and Physicians Committee in Washington, who wasn't part of the study, said that findings from animal experiments often don't translate to humans and that she'd like to see research from population studies with women.


News Article | February 15, 2017
Site: www.eurekalert.org

WASHINGTON -- In the first successful randomized trial of its kind, researchers have provided preliminary evidence that telephone-based smoking cessation counseling given to smokers shortly after undergoing lung cancer screening can be effective at helping people stop smoking. "We found that at this teachable moment -- a time when smokers are thinking about their health and may be ready to make a change -- offering help makes a difference, and may help save lives," says the study's lead researcher, Kathryn L. Taylor, PhD, a behavioral scientist and a professor of oncology at Georgetown Lombardi Comprehensive Cancer Center. The study, led by researchers at Georgetown Lombardi, was conducted with 92 participants at three centers -- MedStar Georgetown University Hospital in Washington, DC, Hackensack University Medical Center in New Jersey, and Lahey Hospital and Medical Center in Massachusetts. "Millions of current smokers are now eligible for lung cancer screening, so this setting represents an important opportunity to exert a large public health impact on cessation among smokers who are at very high risk for multiple tobacco-related disorders," she says. "This is a great way to engage smokers who have not sought out cessation help." These study findings were so promising that investigators have been funded through NIH to conduct a much larger study of telephone-based cessation counseling. It will enroll 1,300 patients at five medical centers nationwide. Lung cancer screening recommendations issued in 2013 by the U.S. Preventive Services Task Force suggest that people who have smoked long enough to have accumulated a minimum of 30 pack-years (i.e., one pack per day for 30 years, or two packs per day for 15 years, etc.) should have an annual low-dose CT lung cancer screening test. The idea is to intervene early enough that disease spotted on the screening can be effectively treated. In the U.S., lung cancer is the leading cancer killer in both men and women -- almost 160,000 Americans were expected to die from lung cancer in 2016, according to the American Lung Association. Taylor points out that the NIH has said that effective smoking cessation programs should be a part of screening programs, and has funded several groups of researchers to develop effective strategies. In this preliminary study, 92 people about to undergo lung cancer screening agreed to receive either telephone counseling or standard of care (a list of free and low-cost cessation resources). Once participants received their screening results, they were randomized to one of the two groups, each with 46 participants. Each group had an equal number of participants with abnormal screening findings, indicating possible precancerous lesions or chronic obstructive pulmonary disease (COPD). Each group also contained an equal number of participants with minor abnormalities on their screen, as well as those with normal results. None of the participants were diagnosed with lung cancer. Participants in the telephone-counseling group were given their first session after finding out their screening results. Over the next three months, six 10-15 minute sessions were conducted. At the end of the study, a nicotine saliva test was given to participants who said they had quit in order to confirm their abstinence. Researchers found that eight (17 percent) people in the telephone counseling group had verifiably quit, compared to two (4 percent) in the other group. "If this preliminary study is replicated, telephone counseling has the potential to improve cessation in a setting that reaches a large number of hard-to-reach, long-term smokers who are at very high risk for multiple tobacco-related diseases," Taylor says. Charlotte Hagerman, who along with Taylor, offered the telephone counseling to participants, describes the counseling as "a motivational intervention. Everyone acknowledged that smoking is very harmful to their health, but some people thought it was too late to change their fate. Counseling helped them understand that it is not too late." Population-based studies have shown that older smokers who quit can have an increased life expectancy, Taylor says. Hagerman says there were also a number of participants who "were ready to quit, and were very excited to receive the help we were offering. I found this very gratifying, and felt that what we were doing was important and mattered to people," says Hagerman, who was trained as a tobacco treatment specialist for the study. "More than 50 percent of participants said in their first interview that they were not ready to quit, yet some of these people did quit. This finding indicates that it is important to offer the cessation intervention to everyone who undergoes lung cancer screening, and not only those who are already considering quitting. This is exactly what we hope for - to be able to reach the people who are not already planning to quit on their own," says Taylor. In addition to Taylor and Hagerman, co-authors from Georgetown University Medical Center include George Luta, PhD; Paula G. Bellini, MA; and Cassandra Stanton, PhD. David B. Abrams, PhD, and Ray Niaura, PhD, are Georgetown faculty and also affiliated with the Schroeder Institute for Tobacco Research and Policy Studies. Jenna A. Kramer, NP and Eric D. Anderson, MD are from MedStar Georgetown University Hospital in Washington, DC; Shawn Regis, PhD, Andrea McKee, MD, and Brady McKee, MD, are from Lahey Hospital and Medical Center, Burlington, MA; and Harry Harper, MD and Michael Ramsaier, BS are from Hackensack University Medical Center, Hackensack, NJ. The authors report having no personal financial interests related to the study. The study was supported by the Prevent Cancer Foundation and Georgetown Lombardi's NCI Cancer Center Support Grant P30 CA051008. Georgetown Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute as a comprehensive cancer center -- the only cancer center of its kind in the Washington, DC area. A part of Georgetown University Medical Center and MedStar Georgetown University Hospital, Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer). Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter) and Instagram (@gumedcenter).


Bhatt R.S.,Beth Israel Deaconess Medical Center | Atkins M.B.,Georgetown Lombardi Comprehensive Cancer Center
Clinical Cancer Research | Year: 2014

The vascular endothelial growth factor (VEGF) pathway is critical for tumor angiogenesis. However, VEGF pathway inhibition has been limited by intrinsic and acquired resistance. Simultaneously targeting multiple steps involved in tumor angiogenesis is a potential means of overcoming this resistance. Activin like kinase 1 (ALK1) and endoglin (ENG) have effects on angiogenesis that are distinct from those of VEGF. Whereas VEGF is important for vessel initiation, ALK1 and endoglin are involved in vessel network formation. Thus, ALK1 and endoglin pathway inhibitors are attractive partners for VEGF-based combination antiangiogenic therapy. Genetic evidence supports a role for this receptor family and its ligands, bone morphogenetic proteins (BMP) 9 and 10, in vascular development. Patients with genetic alterations in ALK1 or endoglin develop hereditary hemorrhagic telangiectasia, a disorder characterized by abnormal vessel development. There are several inhibitors of the ALK1 pathway advancing in clinical development for treatment of various tumor types, including renal cell and ovarian carcinomas. Targeting of alternate angiogenic pathways, particularly in combination with VEGF pathway blockade, holds the promise of optimally inhibiting angiogenically driven tumor progression. ©2014 AACR.


Philips G.K.,Georgetown University | Atkins M.,Georgetown Lombardi Comprehensive Cancer Center
International Immunology | Year: 2015

Despite extensive investigation over the past three decades, cancer immunotherapy has produced limited success, with few agents achieving approval by the Food and Drug Administration and even the most effective helping only a minority of patients, primarily with melanoma or renal cancer. In recent years, immune checkpoints that maintain physiologic self-tolerance have been implicated in the down-regulation of anti-tumor immunity. Efforts to restore latent anti-tumor immunity have focused on antibody-based interventions targeting CTL antigen 4 (CTLA-4) and programmed cell death protein 1 (PD-1) on T lymphocytes and its principal ligand (PD-L1) on tumor cells. Ipilimumab, an antibody targeting CTLA-4, appears to restore tumor immunity at the priming phase, whereas anti-PD-1/PD-L1 antibodies restore immune function in the tumor microenvironment. Although ipilimumab can produce durable long-term responses in patients with advanced melanoma, it is associated with significant immune-related toxicities. By contrast, antibodies targeting either PD-1 or PD-L1 have produced significant anti-tumor activity with considerably less toxicity. Activity was seen in patients with melanoma and renal cancer, as well as those with non-small-cell lung, bladder and head and neck cancers, tumors not previously felt to be sensitive to immunotherapy. The tolerability of PD-1-pathway blockers and their unique mechanism of action have made them ideal backbones for combination regimen development. Combination approaches involving cytotoxic chemotherapy, anti-angiogenic agents, alternative immune-checkpoint inhibitors, immunostimulatory cytokines and cancer vaccines are currently under clinical investigation. Current efforts focus on registration trials of single agents and combinations in various diseases and disease settings and identifying predictive biomarkers of response. © The Japanese Society for Immunology. 2014. All rights reserved.

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