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DCIS for Ductal Carcinoma (PREDICT Trial)

N/A
Waitlist Available
Led By Charles E Cox, MD
Research Sponsored by PreludeDx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the utility of the DCISionRT™ test in the diagnosis and treatment of ductal carcinoma in situ of the breast.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Cases with Changes in Treatment Recommendation
Secondary outcome measures
Function of Demographic Factors
Function of Tumor Factors
Other outcome measures
Distribution of DCISionRT scores across the cohort
Function of Geographic Region

Trial Design

1Treatment groups
Experimental Treatment
Group I: DCISExperimental Treatment1 Intervention
Patients must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast without evidence of invasive cancer (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable)

Find a Location

Who is running the clinical trial?

PreludeDxLead Sponsor
1 Previous Clinical Trials
1,500 Total Patients Enrolled
University of South FloridaOTHER
422 Previous Clinical Trials
186,727 Total Patients Enrolled
Charles E Cox, MDPrincipal InvestigatorUniversity of South Florida
1 Previous Clinical Trials
226 Total Patients Enrolled
~353 spots leftby Nov 2025
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