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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: May 9, 2009
Last updated: November 5, 2010
Last verified: November 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 Intervention
Breast Cancer
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer [ Designated as safety issue: No ]

Enrollment: 1452
Study Start Date: October 2001
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy women undergoing screening mammography or breast biopsy.



  • 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



  • 25 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • No hemophilia
  • No other bleeding disorders


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • No prior double mastectomy


  • No concurrent treatment for breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00897416

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Nicole Urban, ScD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Nicole Urban, ScD, Fred Hutchinson Cancer Research Center Identifier: NCT00897416     History of Changes
Other Study ID Numbers: 5518, FHCRC-5518, CDR0000355401
Study First Received: May 9, 2009
Last Updated: November 5, 2010
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on October 09, 2015