The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing (NCT04916808) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing
Australia1,500 participantsStarted 2021-07-02
Plain-language 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.
Who can participate
Age range
26 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
. 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
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
. 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