Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma
Conditions
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.
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
PROCEDUREBiospecimen Collection
Undergo collection of blood samples
OTHERElectronic Health Record Review
Review of records
OTHERQuality-of-Life Assessment
Complete quality-of-life questionnaires
OTHERSurvey Administration
Complete surveys
Sponsors
University of Southern California
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biorepository | 5 years | Number of biological samples collected and stored (blood) |
Countries
United States
Contacts
CONTACTAudrey Saghian, MPH
PRINCIPAL_INVESTIGATORBodour Salhia, PhD
University of Southern California
Outcome results
None listed