A Study of Breast Cancer Risk Factors and Outcomes of People in Florida
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Patients who are less than 18 years of age will be considered ineligible.
Patients unable to complete the survey.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biospecimen Collection
Other interventionBlood collection at baseline and time of surgery
Surgical Tissue Collection
Diagnostic testTissue collection will be attempted at time of surgery
Survey Collection
BehavioralSurvey collection at baseline, post-surgery, at 1, 3 and 5 year follow up visits
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Participants with BIRADS 0-53 interventions
Trial outcomes
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.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov