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Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women


N/A
25 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Nicole Urban, ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

5518

NCT ID:

NCT00897416

Start Date:

October 2001

Completion Date:

June 2007

Related Keywords:

  • Breast Cancer
  • breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

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