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NCT01160510 · ClinicalTrials.gov registry record
Genetics of Mammographic Appearances and Patterns (The GenMap Study)
A clinical trial of Benign Breast Disease, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 106
- Enrollment target
- 1
- Study location
NCT01160510: Completed study of Benign Breast Disease, sponsored by National Cancer Institute (NCI).
NCT01160510 is a study of Benign Breast Disease that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 106 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160510, a study of Benign Breast Disease, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
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 d
Primary Outcome
Mammagraphic density at screening
Conditions Studied
Study Locations (1)
Vermont
- Vermont Cancer Center - Univ of Vermont - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2010-06-24 |
| Est. Completion | 2020-03-10 |
What the finished NCT01160510 record still lists
NCT01160510 is an observational study that tracks outcomes without assigning an intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Benign Breast Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01160510 reports a single indexed study location in Vermont.
Frequently Asked Questions
What is clinical trial NCT01160510 about?
NCT01160510 is a clinical study titled "Genetics of Mammographic Appearances and Patterns (The GenMap Study)". 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 dete...
What is the current status of trial NCT01160510?
This trial is currently completed. The enrollment target is 106 participants. The study started on 2010-06-24. Estimated completion is 2020-03-10.
What conditions does trial NCT01160510 study?
This clinical trial studies the following conditions: Benign Breast Disease.
Who is sponsoring clinical trial NCT01160510?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01160510 being conducted?
This trial has 1 study location across Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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