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The purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Other | Blood collection at baseline and time of surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neha Goel, MD, MPH | Contact | 646-888-4731 | goeln1@mskcc.org | |
| George Plitas, MD | Contact | 646-888-5368 | plitasg@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Neha Goel, MD, MPH | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles (Specimen Analysis only) | Not yet recruiting | Los Angeles | California | 90095 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Optional blood and/or tissue samples at the time of participant scheduled biopsy procedure in radiology
| Surgical Tissue Collection | Diagnostic Test | Tissue collection will be attempted at time of surgery |
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| Survey Collection | Behavioral | Survey collection at baseline, post-surgery, at 1, 3 and 5 year follow up visits |
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| University of Miami (Data Collection Only) | Recruiting | Miami | Florida | 33136 | United States |
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| Memorial Sloan Kettering Cancer Center (All protocol activites) | Recruiting | New York | New York | 10065 | United States |
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