A Study of Breast Cancer Risk Factors and Outcomes of People in Florida
Genomic and Non-Genomic Factors Associated With Breast Cancer Risk Factors and Outcomes in a Diverse South Florida Population
1 other identifier
observational
800
1 country
3
Brief Summary
The purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2025
CompletedStudy Start
First participant enrolled
January 13, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 13, 2030
February 6, 2026
February 1, 2026
5 years
January 13, 2025
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical characteristic of participants (survey)
The purpose of this study is to prospectively collect and store clinical data, blood and tissue samples, and participant survey data to evaluate (epi) genomic and non-genomic causes of disparity.
Up to 5 years
Study Arms (1)
Participants with BIRADS 0-5
Men and woman 18 years and older who are participants with BIRADS 0-5 who present to breast radiology for biopsy or any new breast patient.
Interventions
Tissue collection will be attempted at time of surgery
Survey collection at baseline, post-surgery, at 1, 3 and 5 year follow up visits
Blood collection at baseline and time of surgery
Eligibility Criteria
University of Miami treating clinicians will identify participants (anyone meeting inclusion criteria listed above) during their regularly scheduled visits (Breast radiology at time of initial biopsy, Surgery clinic visit, Medical Oncology clinic visit) or in the pre-operative waiting area prior to surgery.
You may qualify if:
- Patients with BIRADS 0-5, seen in breast radiology clinic at University of Miami (UM), Sylvester Comprehensive Cancer Center (SCCC), Jackson Health Systems (JHS) for biopsy.
- Any new breast patient seen at UM/SCCC or JHS will be invited to participate in the study.
- Men and women 18 years of age and older are eligible to participate in the study.
You may not qualify if:
- Patients who are less than 18 years of age will be considered ineligible.
- Patients unable to complete the survey.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of California, Los Angeles (Specimen Analysis only)
Los Angeles, California, 90095, United States
University of Miami (Data Collection Only)
Miami, Florida, 33136, United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065, United States
Related Links
Biospecimen
Optional blood and/or tissue samples at the time of participant scheduled biopsy procedure in radiology
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neha Goel, MD, MPH
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2025
First Posted
January 17, 2025
Study Start
January 13, 2025
Primary Completion (Estimated)
January 13, 2030
Study Completion (Estimated)
January 13, 2030
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.