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Breast Cancer Survivorship Biorepository

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT05786664
Collaborator
National Cancer Institute (NCI) (NIH)
1,300
Enrollment
1
Location
72
Anticipated Duration (Months)
18.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Electronic Health Record Review
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors.
SECONDARY OBJECTIVES:

  1. 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.

  2. 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 Design

Study Type:
Observational
Anticipated Enrollment :
1300 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Comprehensive Breast Cancer Survivorship Biorepository
Actual Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Apr 11, 2027
Anticipated Study Completion Date :
Apr 11, 2028

Arms and Interventions

Arm 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: Electronic Health Record Review
    Review of records

    Other: Quality-of-Life Assessment
    Complete quality-of-life questionnaires
    Other Names:
  • Quality of Life Assessment

    • Other: Survey Administration
    Complete surveys

    Outcome Measures

    Primary Outcome Measures

    1. Biorepository [5 years]

      Number of biological samples collected and stored (blood)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Bodour Salhia, PhD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT05786664
    Other Study ID Numbers:
    • 1B-21-6
    • NCI-2021-13442
    • 1B-21-6
    • P30CA014089
    First Posted:
    Mar 27, 2023
    Last Update Posted:
    Mar 27, 2023
    Last Verified:
    Mar 1, 2023
    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
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Mar 27, 2023