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Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
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
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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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
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
| 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) |
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 (Adult, Senior) |
| Sexes 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
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 ClinicalTrials.gov identifier: NCT00897416
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
| 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 ( Registry Identifier: PDQ ) |
| Study First Received: | May 9, 2009 |
| Last Updated: | November 5, 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 Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on July 19, 2017