Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
|ClinicalTrials.gov Identifier: NCT00897416|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : November 9, 2010
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||1452 participants|
|Official Title:||Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
- Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897416
|Principal Investigator:||Nicole Urban, ScD||Fred Hutchinson Cancer Research Center|