Breast Cancer Survivorship Biorepository

NCT05786664 | Recruiting DMC

• 3 other identifiers: 1B-21-6NCI-2021-13442P30CA014089
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Biorepository

  Number of biological samples collected and stored (blood)

  5 years

Study Arms (1)

Observational (survey, biospecimen collection, record review)

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

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

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (survey, biospecimen collection, record review)

Electronic Health Record Review OTHER

Review of records

Observational (survey, biospecimen collection, record review)

Quality-of-Life Assessment OTHER

Complete quality-of-life questionnaires

Also known as: Quality of Life Assessment

Observational (survey, biospecimen collection, record review)

Survey Administration OTHER

Complete surveys

Observational (survey, biospecimen collection, record review)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women diagnosed with invasive breast cancer (stages I-III) who have completed active treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bodour Salhia, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey Saghian, MPH

CONTACT

323-865-6086; amsaghia@usc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 27, 2023
• Study Start: April 11, 2022
• Primary Completion (Estimated): April 11, 2027
• Study Completion (Estimated): April 11, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)