Breast CancerNCT06780176
A Study of Breast Cancer Risk Factors and Outcomes of People in Florida
An observational study of Breast Cancer and Breast Neoplasms, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
The purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Diseases
- What is being tested?
- Biospecimen Collection, Surgical Tissue Collection and Survey Collection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jan 2025to 13 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who are less than 18 years of age will be considered ineligible.
- Patients unable to complete the survey.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of California, Los Angeles (Specimen Analysis only)
Los Angeles, California, 90095
Steven Cole, PhD, (310) 267-4243
- Recruiting
University of Miami (Data Collection Only)
Miami, Florida, 33136
Neha Goel, MD, PhD, 305-243-4902, neha.goel@med.miami.edu
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
Neha Goel, MD, MPH, 646-888-4731
About this study
Official title: 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.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Diseases
- Being tested
- Biospecimen Collection, Surgical Tissue Collection, Survey Collection
- Keywords
- breast cancer, breast neoplasms, breast diseases, BIRADS, Memorial Sloan Kettering Cancer Center, 24-372
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionOther
Blood collection at baseline and time of surgery
Surgical Tissue CollectionDiagnostic test
Tissue collection will be attempted at time of surgery
Survey CollectionBehavioural
Survey collection at baseline, post-surgery, at 1, 3 and 5 year follow up visits
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biospecimen Collection; Diagnostic Test: Surgical Tissue Collection; Behavioral: Survey Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Jan 2025
- Primary completion13 Jan 2030 (estimated)
- Study completion13 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Goel, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780176
- Sponsor's protocol ID
- 24-372
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic and Non-Genomic Factors Associated With Breast Cancer Risk Factors and Outcomes in a Diverse South Florida Population
- ClinicalTrials.gov ID
- NCT06780176
- Acronym / sponsor ID
- 24-372
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Diseases
- Keywords
- breast cancer, breast neoplasms, breast diseases, BIRADS, Memorial Sloan Kettering Cancer Center, 24-372
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 13 Jan 2030 (estimated)
- Study completion
- 13 Jan 2030 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with BIRADS 0-5 | – | Other: Biospecimen Collection, Diagnostic Test: Surgical Tissue Collection, Behavioral: Survey CollectionMen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are less than 18 years of age will be considered ineligible.
- Patients unable to complete the survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionBlood collection at baseline and time of surgery | Other | Participants with BIRADS 0-5 |
| Surgical Tissue CollectionTissue collection will be attempted at time of surgery | Diagnostic test | Participants with BIRADS 0-5 |
| Survey CollectionSurvey collection at baseline, post-surgery, at 1, 3 and 5 year follow up visits | Behavioural | Participants with BIRADS 0-5 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neha Goel, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Neoplasms, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neha Goel, MD, MPH (646-888-4731, goeln1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristic of participants (survey) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.