Breast Cancer Survivorship Biorepository

NCT ID: NCT05786664

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-11

Study Completion Date

2028-04-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (survey, biospecimen collection, record review)

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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Electronic Health Record Review

Intervention Type OTHER

Review of records

Quality-of-Life Assessment

Intervention Type OTHER

Complete quality-of-life questionnaires

Survey Administration

Intervention Type OTHER

Complete surveys

Interventions

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Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Electronic Health Record Review

Review of records

Intervention Type OTHER

Quality-of-Life Assessment

Complete quality-of-life questionnaires

Intervention Type OTHER

Survey Administration

Complete surveys

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bodour Salhia, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Audrey Saghian, MPH

Role: CONTACT

323-865-6086

Facility Contacts

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Audrey Saghian, MPH

Role: primary

323-865-6086

Other Identifiers

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NCI-2021-13442

Identifier Type: REGISTRY

Identifier Source: secondary_id

1B-21-6

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1B-21-6

Identifier Type: -

Identifier Source: org_study_id

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