Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer

Fred Hutchinson Cancer Center1,452 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,452

Conditions

Breast Cancer

Interventions

laboratory biomarker analysisOTHER

Eligibility

Sex: FEMALEMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Planning to undergo outpatient annual mammogram or biopsy AND meets 1 of the following criteria: * High risk for breast cancer * High risk with newly-diagnosed\* breast cancer * Average risk for breast cancer * Average risk with newly-diagnosed\* breast cancer * Benign breast disease NOTE: \* Diagnosed at time of study enrollment * No other breast cancer diagnosis within the past year * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 25 and over Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * No hemophilia * No other bleeding disorders Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * At least 6 months postpartum * No planned pregnancy within the next year * No history of medical conditions that would increase participant risk of blood draws * No psychiatric, psychological, or other condition that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * No prior double mastectomy Other * No concurrent treatment for breast cancer

Outcomes

Primary Outcomes

Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer

Data from ClinicalTrials.gov

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