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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00897416
First received: May 9, 2009
Last updated: November 5, 2010
Last verified: November 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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:

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.

  Eligibility

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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897416

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Nicole Urban, ScD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov 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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013