Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
RATIONALE: Collecting and storing samples of blood and studying them in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is examining biomarkers in women with a high risk or average risk of breast cancer.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women|
- Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer [ Designated as safety issue: No ]
|Study Start Date:||October 2001|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
- Identify and validate serum biomarkers that can distinguish malignant from benign and normal breast conditions in women at high risk or average risk for breast cancer.
- Standardize procedures for recruitment, characterization, and follow-up of participants and collection, processing, storage, and analysis of specimens.
- Assess marker variability over time in healthy controls.
- Develop a shared specimen resource to support ongoing early detection research.
OUTLINE: Blood samples are collected every 6 months and assayed for the presence of biomarkers.
PROJECTED ACCRUAL: A total of 625 participants will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897416
|Principal Investigator:||Nicole Urban, ScD||Fred Hutchinson Cancer Research Center|