Breast Cancer Clinical Trial
Official title:
Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
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