Breast Cancer Survivorship Biorepository

Recruiting

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Invasive Breast Carcinoma

• Registration Number: NCT05786664
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study Start: 2022-04-11
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-27
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-11
• Primary Completion: 2027-04-11
• Study Completion: 2028-04-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biorepository	5 years	Number of biological samples collected and stored (blood)

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States