Status:
COMPLETED
Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
25+ years
Brief Summary
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. PURPO...
Detailed Description
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. Seconda...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
1452 Patients enrolled
Trial Details
Trial ID
NCT00897416
Start Date
October 1 2001
End Date
June 1 2007
Last Update
November 9 2010
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