RecruitingNCT04916808

The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

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

Sponsor

PreludeDx

Enrollment

1,500 participants

Start Date

Jul 2, 2021

Study Type

OBSERVATIONAL

Conditions

DCIS

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.

Eligibility

Sex: FEMALEMin Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This study is following women with a pre-cancerous breast condition called ductal carcinoma in situ (DCIS) who have had a genetic test called DCISionRT to help decide whether they need radiation therapy after surgery. **You may be eligible if:** - You have been diagnosed with DCIS (a non-invasive form of breast cancer) in one breast - Your doctor has already ordered the DCISionRT test as part of your standard care - You had or will have breast-conserving surgery (lumpectomy, not full mastectomy) - You are female and older than 25 - You consent within 120 days of your surgery **You may NOT be eligible if:** - There is not enough tissue available to complete the DCISionRT test - You have invasive breast cancer or cancer in both breasts - You have already had a mastectomy for DCIS - You have a history of prior DCIS or invasive breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDCISionRT 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).