A Study of Breast Cancer Risk Factors and Outcomes of People in Florida

February 4, 2026 updated by: Memorial Sloan Kettering Cancer Center

Genomic and Non-Genomic Factors Associated With Breast Cancer Risk Factors and Outcomes in a Diverse South Florida Population

The purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • University of California, Los Angeles (Specimen Analysis only)
        • Contact:
          • Steven Cole, PhD
          • Phone Number: 310-267-4243
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami (Data Collection Only)
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
        • Contact:
          • Neha Goel, MD, MPH
          • Phone Number: 646-888-4731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who are less than 18 years of age will be considered ineligible.
  • Patients unable to complete the survey.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Biospecimen Collection
Blood collection at baseline and time of surgery
Diagnostic test: Surgical Tissue Collection
Tissue collection will be attempted at time of surgery
Behavioral: Survey Collection
Survey collection at baseline, post-surgery, at 1, 3 and 5 year follow up visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristic of participants (survey)
Time Frame: Up to 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Neha Goel, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Estimated)

January 13, 2030

Study Completion (Estimated)

January 13, 2030

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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