Breast Cancer Survivorship Biorepository
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Electronic Health Record Review, Quality-of-Life Assessment, Survey Administration.
- Who it may be relevant to
- Registry 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. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Comprehensive Breast Cancer Survivorship Biorepository
Overview
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
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of blood samples - Other Electronic Health Record Review
Review of records - Other Quality-of-Life Assessment
Complete quality-of-life questionnaires - Other Survey Administration
Complete surveys
Primary outcome measures
- Biorepository [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- USC / Norris Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT05786664 · 1B-21-6 · NCI-2021-13442 · 1B-21-6 · P30CA014089