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NCT05786664 Clinical Trial

Breast Cancer Survivorship Biorepository

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:
A Comprehensive Breast Cancer Survivorship Biorepository

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05786664
Other study ID # 1B-21-6
Secondary ID NCI-2021-134421B
Status Recruiting
Phase
First received
Last updated
Start date April 11, 2022
Est. completion date April 11, 2028

Study information
Verified date March 2024
Source University of Southern California
Contact Audrey Saghian, MPH
Phone 323-865-6086
Email amsaghia@usc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1300
Est. completion date April 11, 2028
Est. primary completion date April 11, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples
Other:
• Electronic Health Record Review
Review of records
• Quality-of-Life Assessment
Complete quality-of-life questionnaires
• Survey Administration
Complete surveys

Locations
Country Name City State
United States USC / Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biorepository Number of biological samples collected and stored (blood) 5 years
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