Breast Cancer Survivorship Biorepository

University of Southern California

Status: Enrolling

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

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05786664

NCI-2021-13442 (Registry Identifier)

1B-21-6 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,300 participants in 1 patient group

Observational (survey, biospecimen collection, record review)

Description:

Patients complete surveys, undergo collection of blood samples, and review of medical records on study.

Treatment:

Other: Quality-of-Life Assessment

Procedure: Biospecimen Collection

Other: Survey Administration

Other: Electronic Health Record Review