Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04916808




Registration number
NCT04916808
Ethics application status
Date submitted
1/06/2021
Date registered
8/06/2021
Date last updated
21/09/2021

Titles & IDs
Public title
The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing
Scientific title
A Prospective Registry Studyto Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy
Secondary ID [1] 0 0
U1111-1266-0439
Secondary ID [2] 0 0
P2101
Universal Trial Number (UTN)
Trial acronym
AUS-PREDICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
DCIS 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - DCISionRT Test

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).


Diagnosis / Prognosis: 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).
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Cases with Changes in Treatment Recommendation
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Function of Demographic Factors
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Function of Tumor Factors
Timepoint [2] 0 0
5 years

Eligibility
Key inclusion criteria
1. A clinical decision has been made to order the DCISionRT™ Test as part of routine patient care
2. 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)
3. Patient must be consented within 120 days after surgery
4. Patient must be eligible for, or have already received breast conserving surgery
5. Patient must be eligible to receive radiation and/or systemic treatment
6. Patient must be female and greater than 25 years old
7. Patient must be able to provide informed consent
Minimum age
26 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing
2. 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
3. Patient has already been surgically treated with a mastectomy for primary DCIS
4. Patient has prior in situ or invasive breast cancer

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2034
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GenesisCare - Alexandria
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2015 - Alexandria
Recruitment postcode(s) [2] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PreludeDx
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04916808
Trial related presentations / publications
Bremer et al. Cancer Research. Feb 2017. Vol 77 Issue 4 Supp. SABCS16-S5-0.1
Public notes

Contacts
Principal investigator
Name 0 0
Troy Bremer
Address 0 0
Prelude Corp
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tracy Pearce
Address 0 0
Country 0 0
Phone 0 0
+61 3 94276500
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04916808