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The PREDICT Registry:

NCT03448926 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-04-17

No results posted yet for this study

Summary

This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.

Conditions

  • DCIS
  • Stage 0 Breast Cancer
  • Ductal Breast Carcinoma In Situ

Interventions

OTHER

Treatment recommendation surveys

Treatment Recommendation Surveys are completed by the treating physicians before and after receiving results from the DCISionRT test, which is prognostic for risk of recurrence over 10 years and predictive for benefit from radiation therapy.

DEVICE

7-gene biosignature

Ordering the 7-gene biosignature assay (DCISionRT) as a part of routine care for DCIS is a prerequisite (inclusion criterion) for the study. The study is not designed to determine the efficacy of the assay, rather it is designed to meausre the impact of the assay results on treatment decisions for patients with DCIS.

Sponsors & Collaborators

  • PreludeDx

    lead INDUSTRY

Principal Investigators

  • Troy Bremer, PhD · PreludeDx

  • Pat W Whitworth, MD · PreludeDx

  • Rachel Rabinovitch, MD · University of Colorado, Denver

  • Pat Borgen, MD · Maimonides Medical Center

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2026-12-31
Completion
2036-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448926 on ClinicalTrials.gov