The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing
AUS-PREDICT
A Prospective Registry Studyto Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy
2 other identifiers
observational
1,500
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedStudy Start
First participant enrolled
July 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2034
ExpectedSeptember 21, 2021
September 1, 2021
2.8 years
June 1, 2021
September 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Cases with Changes in Treatment Recommendation
The study will collect details on physician treatment recommendations before and after availability of the genomic test (DCISionRT) results. The data elements include type of surgery (lumpectomy, therapeutic mastectomy, contralateral prophylactic mastectomy), type of radiation therapy (none, IORT, APBI, whole breast RT) and endocrine therapy (yes, no). The main measure will be percent of cases in which treatment recommendations are changed after the test results become available.
5 years
Secondary Outcomes (2)
Function of Demographic Factors
5 years
Function of Tumor Factors
5 years
Other Outcomes (2)
Distribution of DCISionRT scores across the cohort
5 years
Function of Geographic Region
5 years
Study Arms (1)
Ductal Carcinoma In Situ (DCIS)
Patients must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast without evidence of invasive cancer (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
Interventions
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).
Eligibility Criteria
The study population will be selected from the clinical practices of the participating investigators and institutions. Patients who have been recently diagnosed with DCIS and are being evaluated for the need for further therapy will be screened for eligibility per the following eligibility criteria.
You may qualify if:
- A clinical decision has been made to order the DCISionRT™ Test as part of routine patient care
- Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable)
- Patient must be consented within 120 days after surgery
- Patient must be eligible for, or have already received breast conserving surgery
- Patient must be eligible to receive radiation and/or systemic treatment
- Patient must be female and greater than 25 years old
- Patient must be able to provide informed consent
You may not qualify if:
- Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing
- Patient has invasive breast cancer or evidence in the ipsilateral or contralateral breast of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple
- Patient has already been surgically treated with a mastectomy for primary DCIS
- Patient has prior in situ or invasive breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PreludeDxlead
Study Sites (2)
GenesisCare
Alexandria, New South Wales, 2015, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Related Publications (1)
Bremer et al. Cancer Research. Feb 2017. Vol 77 Issue 4 Supp. SABCS16-S5-0.1
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Troy Bremer
Prelude Corp
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 8, 2021
Study Start
July 2, 2021
Primary Completion
May 1, 2024
Study Completion (Estimated)
May 1, 2034
Last Updated
September 21, 2021
Record last verified: 2021-09