Status:
RECRUITING
The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing
Lead Sponsor:
PreludeDx
Conditions:
DCIS
Eligibility:
FEMALE
26+ years
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...
Detailed Description
This is a prospective cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria outlined above will be eligible f...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 2 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2034
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04916808
Start Date
July 2 2021
End Date
May 1 2034
Last Update
September 21 2021
Active Locations (2)
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1
GenesisCare
Alexandria, New South Wales, Australia, 2015
2
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050