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The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing
Sponsor: PreludeDx
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
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