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
• Interventions: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Quality-of-Life Assessment; Other: Survey Administration

• 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: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• 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

Arm && Interventions

Group	Intervention	Description
Observational (survey, biospecimen collection, record review)	Biospecimen Collection	Patients complete surveys, undergo collection of blood samples, and review of medical records on study.
Observational (survey, biospecimen collection, record review)	Quality-of-Life Assessment	Patients complete surveys, undergo collection of blood samples, and review of medical records on study.
Observational (survey, biospecimen collection, record review)	Survey Administration	Patients complete surveys, undergo collection of blood samples, and review of medical records on study.
Observational (survey, biospecimen collection, record review)	Electronic Health Record Review	Patients complete surveys, undergo collection of blood samples, and review of medical records on study.

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