MedTrace Logo

The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

NCT04916808 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • DCIS

Interventions

DIAGNOSTIC_TEST

DCISionRT Test

The Prelude DCISionRT Test was developed by Prelude Corporation and is performed at its CLIA laboratory facility. The biomarkers used to evaluate the biologic signature of DCIS tissue are based on over a decade of research including the University of California, San Francisco, Yale University as well as Prelude Corporation. The test is prognostic for 10-year recurrence risk and predicts RT treatment benefit for invasive breast cancer. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing and is accredited by the College of American Pathologists (CAP).

Sponsors & Collaborators

  • PreludeDx

    lead INDUSTRY

Principal Investigators

  • Troy Bremer · Prelude Corp

Eligibility

Min Age
26 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2025-07-30
Completion
2035-12-31
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

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 NCT04916808 on ClinicalTrials.gov