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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03448926




Registration number
NCT03448926
Ethics application status
Date submitted
16/02/2018
Date registered
28/02/2018
Date last updated
19/09/2024

Titles & IDs
Public title
The PREDICT Registry:
Scientific title
A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
Secondary ID [1] 0 0
Ext00000206
Universal Trial Number (UTN)
Trial acronym
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
Other interventions - Treatment Recommendation Surveys

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)


Other interventions: Treatment Recommendation Surveys
Treatment Recommendation Surveys are completed by the treating physicians before and after receiving results from the DCISionRT test, which is prognostic for risk of recurrence over 10 years and predictive for benefit from radiation therapy.
Intervention code [1] 0 0
Other interventions
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
Inclusion criteria

1. 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).
2. Patient must have the DCISionRT test ordered during routine patient care.
3. Patient must be eligible for or have recently completed breast conserving surgery.
4. Patient must be eligible to receive radiation and/or systemic treatment.
5. Patient must be 30 to 85 years old.
6. Patient must have tumor size of less than 6 cm.
7. Patient must have been diagnosed with DCIS within 120 days of consent.
Minimum age
30 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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 evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
3. Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
4. Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
5. Patient has a prior history of in-field radiation in the ipsilateral breast.
6. Patient has had prior systemic endocrine or chemotherapy prior to testing.
7. Patient is pregnant.

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
27/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2035
Actual
Sample size
Target
3000
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
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Illinois
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United States of America
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Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
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United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
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Michigan
Country [11] 0 0
United States of America
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New Jersey
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United States of America
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New York
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Ohio
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PreludeDx
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of South Florida
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.
Trial website
https://clinicaltrials.gov/study/NCT03448926
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, PhD
Address 0 0
PreludeDx
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Steven C Shivers, PhD
Address 0 0
Country 0 0
Phone 0 0
813-215-1749
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/NCT03448926