Registry for patients with ductal carcinoma in situ (DCIS)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to evaluate the impact of the DCISionRT test results on physician treatment recommendations for patients diagnosed with ductal carcinoma in situ (DCIS). Patients will have their most representative tissue samples analyzed, and their treatment preferences will be assessed before and after receiving the test results. The study will follow participants for up to 10 years to gather data on treatment decisions and patient outcomes. All data will be securely stored and de-identified to protect patient privacy.

Why it matters

Who can join: the full rules

Inclusion criteria

1. 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).
2. Patient must have the DCISionRT test ordered during routine patient care.
3. Patient must be eligible for or have recently completed breast conserving surgery.
4. Patient must be eligible to receive radiation and/or systemic treatment.
5. Patient must be 30 to 85 years old.
6. Patient must have tumor size of less than 6 cm.
7. Patient must have been diagnosed with DCIS within 120 days of 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 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.
3. Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
4. Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
5. Patient has a prior history of in-field radiation in the ipsilateral breast.
6. Patient has had prior systemic endocrine or chemotherapy prior to testing.
7. Patient is pregnant.

Where it's running

• Arizona Center for Cancer Care
  Scottsdale, Arizona, United States Recruiting
• University of California San Diego
  La Jolla, California, United States Recruiting
• Sutter Health
  San Mateo, California, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Baptist MD Anderson Cancer Center
  Jacksonville, Florida, United States Recruiting
• BayCare Health System
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Troy Bremer, PhD — PreludeDx
• Study coordinator: Steven C Shivers, PhD
• Email: sshivers@preludedx.com
• Phone: 813-215-1749

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.