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Current Research Projects
Project Title Sleep, Circadian Hormonal Dysregulation and Breast Cancer Survival
Researcher David Spiegel, MD, Stanford School of Medicine, Palo Alto, California
Study Abstract Recent research provides evidence that disrupted circadian rhythms are associated with increased risk of breast cancer incidence and faster progression to mortality. There is also recent evidence that abnormal clock genes are associated with cancer. Our data and those of others increasingly point toward disrupted circadian cycles having an effect on the body’s resistance to cancer. But a number of important questions remain unanswered. We therefore propose to study coping with stress and associated sleep disruption as a prognostic factor in the progression of metastatic breast cancer, and in association with disrupted circadian patterns of cortisol, CRF, ACTH, prolactin, and melatonin, as well as measures of immune function. We plan to recruit 105 women with metastatic breast cancer and 20 age and SES-matched controls for a 28-hour sleep study in the General Clinical Research Center. This study has the potential to link mind and body in cancer through a careful examination of differences in coping with the inevitable stressors associated with cancer as they affect circadian sleep, hormonal, and immune cycles and potentially cancer progression.
Project Title The BEAM Study
Researcher Seema Khan, Northwestern University, Chicago, MD
Study Abstract Current methods to determine breast cancer risk are insufficiently sensitive to select women most likely to benefit from preventive strategies. Our preliminary data support the hypothesis that quantitative molecular markers (DNA methylation and breast tissue hormone concentrations) may provide an individualized risk profile. We will obtain random fine needle aspiration samples from 300 women of varying menopausal and menstrual status and evaluate cumulative gene methylation and breast estradiol concentrations. Ongoing commercial partnership will ensure development of a simple, inexpensive and noninvasive test. This work sets the stage for validation studies to test whether these early changes predict future breast cancer.
Project Title DCIS and BRCA1 and BRCA2 Study
Researcher Elizabeth Claus, MD, PhD, Yale University School of Medicine, New Haven, Connecticut
Study Abstract The role of ductal carcinoma in situ (DCIS) with respect to breast-ovarian cancer syndromes associated with the genes BRCA1 and BRCA2 is unclear. We propose a multi-center, collaborative effort to construct a sample of approximately 175 female BRCA1 and BRCA2 carriers diagnosed with DCIS drawn from a population-based case/control study of DCIS as well as from a number of large high-risk cancer clinics across the United States in an effort to define preliminary estimates of outcome for these women. The goals of this application are: 1) To provide annual and five-year cumulative estimates of ipsilateral and contralateral breast cancer risk, as well as risk of ovarian cancer and death for women diagnosed with DCIS and who have mutations in BRCA1/2, 2) To compare these risks with those for women diagnosed with DCIS and who do not carry mutations in BRCA1 and BRCA2 and those for women not diagnosed with DCIS (controls), 3) To measure and compare the prevalence of pathologic characteristics (estrogen, progesterone, erbB-2, and Ki-67 (MIB-1) receptor positivity as well as tumor size, grade and comedo necrosis) of DCIS diagnosed in women with mutations in BRCA1/2 with those in DCIS patients without such mutations, 4) To present preliminary risk models and clinical guidelines for the management of DCIS in BRCA1 and BRCA2 mutation carriers.
Project Title Discovery of Early Markers of Breast Cancer
Researcher Isabelle Bedrosian, M.D.
Study Abstract Most breast cancer patients have no known antecedent risk factors. Development of tissue based, molecular markers of breast cancer risk would offer a novel means of individualizing risk assessment and may provide new opportunities for prevention. Activation of the DNA damage response (DDR) is an important cellular mechanism for maintaining genomic integrity. We have recently noted that DNA damage is present in histologically normal mammary epithelial cells adjacent to areas of carcinoma, suggesting that DNA damage may be an early molecular marker of malignant transformation that precedes histologic changes. The objective of this study is to evaluate biomarkers of DDR activation in normal breast tissue as predictors of future development of breast cancer. Our primary hypothesis is that activation of the DDR pathway occurs as an early event in breast tumorigenesis and will be positively associated with invasive breast cancer risk.
Project Title The Milk Study: Using Breast Milk to Screen for Breast Cancer and Assess Breast-Cancer Risk
Researcher Kathleen Arcaro, Ph.D. at the Universtiy of Massachusetts, Amherst
Study Abstract Accurate assessment of breast-cancer-risk will benefit most women and analysis of promoter hypermethylation in exfoliated epithelial cells in breast milk provides an ideal opportunity to assess breast-cancer-risk.
Project Title Pathways to Recovery After Breast Cancer
Researcher Annette Stanton, PhD, University of California, Los Angeles, Los Angeles, California
Study Abstract PREPARATORY INTERVENTIONS FOR LIFE AFTER BREAST CANCER (project 3)
In the United States, over 2 million women live with a history of breast cancer. The re-entry transition from cancer patient to survivor is an understudied and challenging period. Using a theory-driven conceptual framework, Project 3 of this Cancer Information Service Research Consortium (CISRC) proposal involves development and testing of interventions to promote informed re-entry to life after breast cancer treatment. To test the efficacy of the intervention, breast cancer callers to the CIS will be enrolled, and depending on computer access, randomized to the 3-group design (n = 1,080 at baseline) or the 2-group design (n = 150 at baseline), and followed at 2, 6, and 12 months post-baseline. Project 3 is unique in that it examines a state-of-the-science software program and proactive CIS-initiated telephone callback, thus addressing the primary service mission of the CIS. Contingent upon findings, the goal of the CISRC is to prepare the intervention for dissemination within the CIS, as well as other service programs nationwide.
Project Title Genomic Markers of Breast Cancer Prevention Induced by hCG in Women at High Risk
Researcher Irma Russo, MD, Fox Chase Cancer Center, Philadelphia, Pennsylvania
Study Abstract This study will test the hypothesis that the genomic profile of breast epithelial cells of asymptomatic nulliparous women carriers of BRCA1 germline mutations is characteristic of such a risk, and that the induction of differentiation by treatment with human chorionic gonadotropin (r-hCG) would revert the “high risk” to a “low risk” signature that would serve as a biomarker indicative of decreased breast cancer risk. Breast epithelial cells will be collected by random periareolar fine needle aspiration from 18 women with BRCA1 mutations. Cells will be cytopathologically evaluated; RNA will be extracted for analysis of gene expression by cDNA microarray, and immunocytochemical determination of cell proliferation by Ki67, ER and PR status, parameters that will serve as a baseline of the “high risk” genomic profile. This knowledge will serve as the basis for establishing novel genomic signatures as intermediate biomarkers for larger preventive clinical trials at the completion of this project.
Project Title The Impact of Colonic Microbiota on Breast Cancer
Researcher Ece Mutlu, MD, Rush University Medical Center, Chicago, Illinois
Study Abstract The purpose of this study is to find out what type of bacteria can be found in the intestines and to look at the way the bacteria metabolize estrogen and other female hormones. The bacteria of women who have never had breast cancer will be compared to the bacteria of women who have been recently diagnosed with breast cancer. Thirty (30) women who have never had breast cancer are needed for this study.
Project Title Protocol for Narrowing the Gap in Adjuvant Therapy
Researcher Vanessa Sheppard, PhD, Georgetown University, Washington, DC
Study Abstract At present, it is estimated that adjuvant therapy would be considered standard of care for up to 80% of women with invasive, non-metastatic disease, but many Black women eligible for adjuvant therapy are not receiving it or are receiving sub-optimal regimens. However, at present there are few data about Black women’s breast cancer experiences or factors that influence treatment adherence. The overarching goal of this career development award is to obtain the skills and experience needed to become an independent investigator focused on filling this knowledge gap.
Project Title Yoga for Breast Cancer Survivors: Effects on Fatigue, Immune Function, and Mood
Researcher Janice Kiecolt-Glaser, PhD, The Ohio State University, Columbus, Ohio
Study Abstract Breast cancer survivors confront a number of post-treatment problems including fatigue, decreased physical function, fears of recurrence, and treatment-related sequelae. Persistent fatigue, the most common and distressing problem, appears to be related in part to overactivation of the inflammatory network.
Project Title Omega-3 Fatty Acid Study and the Glucosamine and Chondroitin Study
Researcher Dawn Hershman, MD
Study Abstract The Omega-3 Fatty Acid Study:
The primary objective of this study is to demonstrate the effect of omega-3-fatty acid as a supplemental therapy to the pharmacological treatment of musculoskeletal pain related to aromatase inhibitors in postmenopausal breast cancer patients.
The Glucosamine and Chondroitin Study:
The primary objective of this study is to demonstrate the effect of glucosamine plus chondroitin as a supplemental therapy to the pharmacological treatment of musculoskeletal pain related to aromatase inhibitors in postmenopausal breast cancer patients.
Project Title Combination of Low-Dose Anti-Estrogens with Omega-3 Fatty Acids for Prevention of Hormone-Independent Breast Cancer
Researcher Andrea Manni, MD, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania
Study Abstract Our hypothesis is that the combination of a low dose of the anti-estrogen raloxifene and the omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect. This expectation is based on the cooperative mechanisms of action of these two interventions. A unique and attractive feature of our proposed research is that it may identify a prevention strategy that will reduce the development of both hormone-dependent and independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors. In addition, we postulate that this approach will be safe, since it will combine a lower and hence a less toxic dose of raloxifene with the administration of omega-3 fatty acids, which are known to have health benefits. The main objectives of this study are to determine the individual and combined effects of raloxifene and omega-3 fatty acids on surrogate markers of breast cancer development in healthy, postmenopausal women. The primary endpoint will be mammographic density, which is a major risk factor for breast cancer. Secondary endpoints include markers of oxidative stress, parameters of estrogen metabolism, markers of inflammation, and markers of IGF-I signaling.
Project Title Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers
Researcher Michael McCulloch, LAc MPH PhD
Study Abstract Epithelial ovarian cancer is the fifth leading cause of cancer death in women. Early diagnosis is the most important step toward reducing morbidity and mortality from epithelial ovarian cancer. Our laboratories have developed preliminary data suggesting that exhaled breath condensate may provide an important source of biomarkers diagnostic of ovarian cancer. Our primary hypothesis is that using patients with epithelial ovarian cancer can be readily distinguished from both healthy controls and endometriosis or polycystic ovarian syndrome controls, using solely analysis of exhaled breath condensate. We propose this distinction can be made using both sophisticated chemical analysis (GC/FT-ICR MS) and a biological method (canine scent detection).
Project Title Healing Choices for Women With Breast Cancer Study
Researcher Peter Raich, MD, University of Colorado, Denver
Study Abstract The overall goal of this randomized, controlled research study is to develop and test a highly innovative multimedia preparatory and educational intervention (CD-ROM and web-based) to facilitate adjustment to diagnosis and informed decision-making for women recently diagnosed with breast cancer. Study participants will be recruited through the Cancer Information Service (CIS) of the National Cancer Institute. This study (N=722) will utilize a two group design, with half the study sample assigned to usual CIS service and half assigned to the multimedia intervention. The main research hypothesis is that the intervention group will experience greater improvement on main study endpoints including cancer-specific distress, decisional conflict, satisfaction with decision-making and knowledge, when compared to the control group. Additional analyses will also be conducted to test both meditational and moderator variables. Contingent on findings, the multimedia intervention will be offered for dissemination within the CIS, as well as in similar service programs nationwide.
Project Title Breathe for Hot Flashes
Researcher Janet Carpenter, PhD, RN, FAAN, Indiana University School of Nursing, Indianapolis
Study Abstract This randomized, controlled trial evaluates a CD-based breathing program against a DVD-based breathing program against no-treatment usual care among breast cancer survivors and menopausal women without breast cancer. Aims are to evaluate (1) efficacy for physiologic and subjective hot flashes (objective frequency and subjective frequency, severity, bother, duration), (2) efficacy for perceived hot flash interference and associated outcomes (mood, affect, sleep), (3) differences in efficacy between breast cancer survivors and menopausal women without cancer, and (4) acceptability and usability in anticipation of disseminating findings into clinical practice (treatment acceptability, outcome expectancy, treatment credibility, and frequency of practice and application). This study will also examine baseline characteristics as potential covariates of efficacy, including objective hot flash frequency, body mass index, race, ethnicity, education, prior breath training, smoking status, menopausal status, use of selective estrogen receptor modulators or aromatase inhibitors, use of other hot flash treatments, and comorbidities.
Project Title Identification of Novel Genetic Risk Factors that Contribute to the Risk for Breast Cancer
Researcher Paul Goodfellow, PhD
Study Abstract Breast cancer takes its greatest toll on young women. Young women frequently have biologically aggressive tumors. They often present with advanced disease and their tumors are frequently hormone non- responsive, thereby limiting treatment options. Young women suffer lower than average disease-free and overall survival. The work proposed is focused on discovery of the as yet unknown genetic risk factors that underlie development of early-onset breast cancer. These findings will pave the way for future studies to elucidate how genetic risk and environmental factors interact and account for the aggressive tumors and poor outcome young breast cancer patients experience. We hypothesize copy number variants (CNVs) play an important role in risk for development of early-onset breast cancer.
Project Title Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
Researcher Michael Irwin, MD, University of California, Los Angeles
Study Abstract This project will constitute the first, randomized clinical trail of the effects of TCC on sleep outcomes in breast cancer survivors, and will advance psychobiological models of insomnia treatment mechanisms.
Project Title Urine and Tumor Markers Study
Researcher Edgardo Rivera, MD
Study Abstract This study will collect the PGE-M and COX-2 IHC levels in subjects with breast cancer to establish whether urinary PGE-M can be used as a surrogate marker for increased COX-2 expression.
AIMS:
1. The primary objective is to determine the level of PGE-M in the urine of breast cancer patients.
2. The secondary objective is to correlate PGE-M expression in urine expression of COX-2 through IHC in tumor tissue.
3. The third objective is to test the difference in urinary PGE-M level between the patients with tumor and patients without tumor.
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