Breast Cancer Survivorship Biorepository

A Comprehensive Breast Cancer Survivorship Biorepository

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.

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Invasive Breast Carcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Other: Electronic Health Record Review; Other: Quality-of-Life Assessment

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 Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Audrey Saghian, MPH; Phone Number: 323-865-6086; Email: Amsaghia@usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Contact: Audrey Saghian, MPH; Phone Number: 323-865-6086; Email: Amsaghia@usc.edu
      • Principal Investigator: Bodour Salhia, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (survey, biospecimen collection, record review); Patients complete surveys, undergo collection of blood samples, and review of medical records on study.	Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Complete surveys; Other: Electronic Health Record Review; Review of records; Other: Quality-of-Life Assessment; Complete quality-of-life questionnaires; Other Names: Quality of Life Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biorepository	Number of biological samples collected and stored (blood)	5 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Bodour Salhia, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Estimated): April 11, 2027
• Study Completion (Estimated): April 11, 2028

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1B-21-6 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2021-13442 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No