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Trial Title:
Breast Cancer Survivorship Biorepository
NCT ID:
NCT05786664
Condition:
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: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Observational (survey, biospecimen collection, record review)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Review of records
Arm group label:
Observational (survey, biospecimen collection, record review)
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Complete quality-of-life questionnaires
Arm group label:
Observational (survey, biospecimen collection, record review)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete surveys
Arm group label:
Observational (survey, biospecimen collection, record review)
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.
Criteria for eligibility:
Study pop:
Adult women diagnosed with invasive breast cancer (stages I-III) who have completed
active treatment.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Audrey Saghian, MPH
Phone:
323-865-6086
Email:
Amsaghia@usc.edu
Investigator:
Last name:
Bodour Salhia, PhD
Email:
Principal Investigator
Start date:
April 11, 2022
Completion date:
April 11, 2028
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05786664
