Registry for patients with ductal carcinoma in situ using DCISionRT testing
A Prospective Registry Studyto Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy
This study is trying to see how the DCISionRT test can help guide treatment decisions for patients with ductal carcinoma in situ (DCIS) and track their outcomes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 26 Years and up |
| Sex | Female |
| Sponsor | PreludeDx Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Alexandria, New South Wales and 1 other locations) |
| Trial ID | NCT04916808 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to create a de-identified database of patients diagnosed with ductal carcinoma in situ (DCIS) and their treatment outcomes. Patients will undergo the DCISionRT test, which analyzes tissue samples to inform treatment decisions. The study will collect data before and after testing, allowing researchers to evaluate the utility of the DCISionRT test in clinical practice. Participants will be followed for up to 10 years to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are females over 25 years old with histologically confirmed DCIS who are eligible for breast conserving surgery and radiation treatment.
Not a fit: Patients with invasive breast cancer or insufficient tissue for testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment decision-making for patients with DCIS, potentially leading to better outcomes.
How similar studies have performed: Other studies utilizing similar testing approaches have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. A clinical decision has been made to order the DCISionRT™ Test as part of routine patient care 2. 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) 3. Patient must be consented within 120 days after surgery 4. Patient must be eligible for, or have already received breast conserving surgery 5. Patient must be eligible to receive radiation and/or systemic treatment 6. Patient must be female and greater than 25 years old 7. Patient must be able to provide informed consent 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 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 3. Patient has already been surgically treated with a mastectomy for primary DCIS 4. Patient has prior in situ or invasive breast cancer
Where this trial is running
Alexandria, New South Wales and 1 other locations
- GenesisCare — Alexandria, New South Wales, Australia (Recruiting)
- Royal Melbourne Hospital — Parkville, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Troy Bremer — Prelude Corp
- Study coordinator: Tracy Pearce
- Email: Tracy.Pearce@genesiscare.com
- Phone: +61 3 94276500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.