The PREDICT Registry: (NCT03448926) | Clinical Trial Compass
RecruitingNot Applicable
The PREDICT Registry:
United States3,000 participantsStarted 2018-02-27
Plain-language 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.
Who can participate
Age range
30 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of Cases with Changes in Treatment Recommendation
Timeframe: From enrollment to the beginning of treatment.
. 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.