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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00897416
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : November 9, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

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.

PURPOSE: This laboratory study is examining biomarkers in women with a high risk or average risk of breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Other: laboratory biomarker analysis

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.

Study Type : Observational
Actual Enrollment : 1452 participants
Time Perspective: Prospective
Official Title: Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women
Study Start Date : October 2001
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00897416

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

Responsible Party: Nicole Urban, ScD, Fred Hutchinson Cancer Research Center Identifier: NCT00897416     History of Changes
Other Study ID Numbers: 5518
CDR0000355401 ( Registry Identifier: PDQ )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

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
Neoplasms by Site
Breast Diseases
Skin Diseases