A Comprehensive Breast Cancer Survivorship Biorepository
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Sponsor
- University of Southern California
- Enrollment
- 1300
- Locations
- 1
- Primary Endpoint
- Biorepository
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.
Detailed Description
PRIMARY OBJECTIVE: I. To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors. SECONDARY OBJECTIVES: I. To collect comprehensive data on social determinants of health (e.g., race/ethnicity, acculturation, socioeconomic status, and access to care), environmental exposures (based on zip codes/geocoding), lifestyle (e.g., diet, tobacco use), clinicopathologic characteristics, treatment history, follow-up and current disease status, survivorship-related issues. II. To establish an efficient process for researchers to utilize the biorepository for breast cancer and survivorship-related studies. OUTLINE: Patients complete surveys, undergo collection of blood samples, and review of medical records on study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women of all racial and ethnic groups 18 years of age or older
- •Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years
- •Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation)
- •Prior participation on clinical trials is allowed
Exclusion Criteria
- •Current receipt of interventional clinical trial participation
- •Stage IV (metastatic) cancer
- •Prior history of recurrence (except recurrence following ductal carcinoma in situ)
- •Inability to give informed consent
- •Unable to speak English, Spanish, Chinese, or Korean
Outcomes
Primary Outcomes
Biorepository
Time Frame: 5 years
Number of biological samples collected and stored (blood)