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
• 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
• 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

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Neoplasms
• Invasive Breast Carcinoma

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