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ACTIVE NOT RECRUITING
NCT04916808

The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

Sponsor: PreludeDx

View on ClinicalTrials.gov

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.

Official title: A Prospective Registry Studyto Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy

Key Details

Gender

FEMALE

Age Range

26 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2021-07-02

Completion Date

2035-12

Last Updated

2026-04-03

Healthy Volunteers

No

Conditions

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).

Locations (2)

GenesisCare

Alexandria, New South Wales, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia