17 Clinical Trials for Various Conditions
The purpose of this study is to determine the safety of three doses of topically applied danazol compared to placebo in subjects with pain associated with fibrocystic breast disease and to determine the appropriate clinical dose for future studies.
Fibrocystic Disease of Breast
RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer to test in the laboratory may help the study of cancer in the future. PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast disease.
Breast Cancer
RATIONALE: Diagnostic procedures that measure biomarker levels in nipple section and blood samples, may help in the early detection of breast cancer. PURPOSE: This clinical trial is studying nipple secretion samples in detecting breast cancer in patients and healthy participants undergoing breast cancer screening, breast diagnostic studies, or treatment for benign breast disease.
Breast Cancer
The overarching goal of the proposed research is to evaluate whether qualitative and quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in assessing suspicious indeterminate cystic appearing breast masses and ultimately determine whether or not an ultrasound guided biopsy is necessary. The underlying hypothesis is that breast masses (given BIRADS 4) that lack enhancement on CEUS will have a benign histology obtained by ultrasound guided core biopsy and/or surgery. Then, in the future, these non-enhancing cystic lesions can be followed and do not need biopsy intervention.
Breast Cancer
This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety, tolerability and potential effects of dietary supplement Violet™ Iodine on breast health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of effectiveness.
Fibrocystic Breast Condition (FBC)
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.
Fibrocystic Disease of Breast, Breast Cancer
* History of clinical breast pain for at least the last six months. * At least six days of moderate or severe breast pain per cycle. * Fibrosis, cysts, nodules involving at least 25% of the surface of one breast. * Euthyroid with no prior history of thyroid disease. * Six months of daily therapy with molecular iodine. * Placebo controlled vs active (1:1).
Fibrocystic Disease of Breast, Fibrocystic Changes of Breast, Fibrocystic Mastopathy, Pain
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D effects mammographic breast density, mammographic texture features, and gene expression profiles in breast biopsy tissue.
Benign Breast Disease
In 2005, The University of Alabama at Birmingham established a NIDDK-funded, interdisciplinary center of excellence in PKD-related research, with specific emphasis on recessive PKD. In the previous Core Center award period, we developed a Core Resource to capture clinical and mutational data for ARPKD patients ("Core A: ARPKD Clinical and Genetic Resource", NCT00575705). However, studies in the last several years have demonstrated that ARPKD and other single gene disorders characterized by renal cystic disease and extra-renal phenotypes share numerous pathogenic features. In the current competitively- renewed Center, we have expanded this Core resource to include other hepato/renal fibrocystic diseases. Goals for the Core A: The Hepato/Renal Fibrocystic Diseases Translational Resource are: 1. - Clinical Database: • Expand our comprehensive Clinical Database to include information from all patients who meet the inclusion criteria for hepato/renal fibrocystic diseases. 2. - Mutational Database: * Test children with ARPKD and other hepato/renal fibrocystic disease to identify genetic mutations, establish a DNA bank for patients with hepato/renal fibrocystic diseases and develop a Mutational Database. This Database will be capable of linking clinical and mutational information via a unique identifier in a searchable format to facilitate genetic research (e.g. genotype-phenotype correlations, new disease gene studies, and modifier gene studies), translational studies, and clinical trials. 3- Tissue Resource: * Much of the research that is performed on diseases of the kidney, including recessive genetic diseases, requires human tissue from both affected as well as non-affected (controls) individuals. In this Core Resource, we are establishing an independent tissue resource which would supply investigators throughout North America with samples of hepato/renal fibrocystic disease affected tissues for studies of these disorders. 4- Educational Resource: * Expand our multi-media, web-based resource to provide a reliable up-to-date, and comprehensive informational resource for ARPKD and Hepato/Renal Diseases families, their physicians, and genetic counselors.
Hepato/Renal Fibrocystic Disease, Autosomal Recessive Polycystic Kidney Disease, Joubert Syndrome, Bardet Biedl Syndrome, Meckel-Gruber Syndrome, Congenital Hepatic Fibrosis, Caroli Syndrome, Oro-Facial-Digital Syndrome Type I, Nephronophthisis, Glomerulocystic Kidney Disease
High mammographic density (HMD) is the strongest risk factor for non-familial breast cancer apart from age and gender. Studies of sisters and twins suggest that approximately 67% of the variation in density is attributable to common genetic factors. However, to date, efforts to identify genetic determinants of HMD have achieved limited success. We and others (Boyd et al Lancet Oncol 2009) postulate that this lack of progress in identifying genetic determinants of density is related to a failure to study younger women and misclassification of density. As women age, their breast tissues undergo atrophy, which is manifested radiologically as a decrease in mammographic density, resulting in a convergence of density values and a masking of inter-person variation. This protocol is intended to demonstrate the feasibility of methods that we plan to use in a full-scale analysis of mammographic density among women under age 50 years who receive care at the University of Vermont, Fletcher Allen Health Care (FAHC) and have been followed through the Vermont Breast Cancer Surveillance System (VBCSS). The Hormonal and Reproductive Epidemiology Branch (HREB) is currently conducting a cross-sectional study entitled, Breast Radiology Evaluation and Study of Tissues (BREAST) Stamp Project which aims to understand why mammographically dense tissues are related to elevated breast cancer risk. This project is being conducted within the VBCSS using breast cancer awareness Stamp Act funds. The BREAST Stamp project has focused on women between the ages of 40-65 years who were referred for radiologically-guided biopsy to evaluate an abnormality identified on a screening mammogram. The study has successfully enrolled over 400 women with collection of questionnaires, buccal and blood samples, and tissues. The study will continue recruiting through May 2010, with a targeted enrollment of 450-500 women. Through the infrastructure developed for the BREAST Stamp Project, mammographic volumetric density data, assessed using a novel method with density phantoms developed at UCSF, has been collected on approximately 25,000 screened women of all ages from February 2008-present. The current protocol describes a study in which we propose to capitalize on infrastructure that has been established through the BREAST Stamp Project. We propose to perform this study in two phases: Phase one will be a feasibility study: specifically, we propose to demonstrate that we can use a mailing to collect Oragene tube format saliva collection kits as a source of germline DNA and a short self-administered questionnaire. This collection of specimens and data will be used to inform the launch of phase two, the full-scale study to identify determinants of mammographic volumetric density among approximately 10,000 women less than 50 years of age for whom raw images and density data are already collected. During the first phase we hope to demonstrate feasibility by achieving at least 60% participation with unbiased representation of subjects with regard to demographics and volumetric density measurements. Once feasibility of this approach is established, we propose to launch the full-scale study by contacting the remaining (approximately 10,000) women with existing volumetric density data to collect questionnaires and DNA samples necessary to delineate the genetic determinants of mammographic density, as well as to investigate hypothesized risk factors for mammographic density and breast cancer risk, such as alcohol intake, cigarette smoking, and breastfeeding history.
Benign Breast Disease
Breast nipple aspirate fluids (NAF) are useful for non-invasive monitoring of the breast. NAF has been shown to exhibit large inter-individual differences in lipid peroxidation. Unfortunately, the yield of epithelial cells in NAF is low. More recently, breast ductal lavage has been approved for clinical use. Nuclear morphologic features of breast biopsies have been shown previously to have prognostic value for breast cancer risk. In women without cancer, there may be subtle changes in the breast epithelial cells that can only be defined with computer-assisted measurements. The subjects selected for this study will be 98 women with biopsy-confirmed proliferative breast disease. These women are at slightly increased breast cancer risk, and exhibit higher mean levels of cholesterol and cholesterol oxides in NAF than women with non-proliferative histology in the breast. Levels of 8-isoprostane, cholesterol, fatty acids, fat-soluble micronutrients and 2,6-cyclolycopene-4,5-diol will be quantified in breast NAF that is obtained before breast lavage. These measures were chosen based on their potential relationship to dietary intakes and to oxidative stress, which is relevant to the application of these methods to dietary prevention studies.The investigators will characterize the morphology of breast epithelial cells from lavage using quantitative image cytometry to capture nuclear and cellular area, diameter, roundness, perimeter, and nuclear:cytoplasmic area ratio. Correlations will be evaluated between the measured morphologic features and each analyte in the NAF. The impact of various clinical, demographic and dietary factors on cellular morphology will also be explored. This study will help establish the feasibility of using these measures as endpoints in dietary intervention studies and will generate hypotheses that should be tested in larger studies. Such measures also should be applicable to molecular epidemiological investigations that seek to examine the impact of certain gene polymorphisms and environmental exposures on biomarkers of cancer risk.
Benign Breast Disease
This phase II trial studies how well abemaciclib works in treating patients with triple negative breast cancer that can be removed by surgery (resectable) and does not respond to treatment with chemotherapy alone, or in combination with pembrolizumab. Abemaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Ductal Carcinoma In Situ, Breast Fibrocystic Change, Breast Lobular Carcinoma In Situ, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators affiliated with it - to develop a repository of specimens with corresponding characteristics from patients seen in the breast care and cancer clinics.
Breast Cancer, Benign Breast Disease
The purpose of this study is to pilot test and evaluate an existing tailored ALEX Research Portal to navigate Black and Hispanic adult cancer patients and their family members through referral to cancer clinical trials.
Cancer
The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.
Moderate to Severe Cyclic Mastalgia
The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry. This registry serves as a clinical database to support research in prevention, early detection and treatment of breast cancer.
Breast Cancer
The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.
Breast Cancer