Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5518
- FHCRC-5518
- CDR0000355401 (Registry Identifier: PDQ)
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