Status:
RECRUITING
The PREDICT Registry:
Lead Sponsor:
PreludeDx
Conditions:
DCIS
Eligibility:
FEMALE
30-85 years
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 criter...
Detailed Description
After a diagnosis of DCIS, the most representative tissue block (or 10 sections mounted on charged slides cut at 3-4 microns) will be sent to PreludeDx for DCISionRT. The most representative specimen ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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 have the DCISionRT test ordered during routine patient care.
- Patient must be eligible for or have recently completed breast conserving surgery.
- Patient must be eligible to receive radiation and/or systemic treatment.
- Patient must be 30 to 85 years old.
- Patient must have tumor size of less than 6 cm.
- Patient must have been diagnosed with DCIS within 120 days of consent.
- Exclusion criteria
- Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
- 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.
- Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
- Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
- Patient has a prior history of in-field radiation in the ipsilateral breast.
- Patient has had prior systemic endocrine or chemotherapy prior to testing.
- Patient is pregnant.
Exclusion
Key Trial Info
Start Date :
February 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT03448926
Start Date
February 27 2018
End Date
December 1 2035
Last Update
September 19 2024
Active Locations (15)
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1
Arizona Center for Cancer Care
Phoenix, Arizona, United States, 85027
2
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
3
Mills-Peninsula Medical Center
San Mateo, California, United States, 94019
4
University of Colorado Denver
Aurora, Colorado, United States, 80045