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Registry for patients with ductal carcinoma in situ (DCIS)

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy

Observational PreludeDx · NCT03448926

This study is trying to see how the results of a specific test for ductal carcinoma in situ (DCIS) can change the treatment choices doctors make for patients with this condition.

Quick facts

Study typeObservational
Enrollment3000 (estimated)
Ages30 Years to 85 Years
SexFemale
SponsorPreludeDx Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations30 sites (Scottsdale, Arizona and 29 other locations)
Trial IDNCT03448926 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients aged 30 to 85 with histologically confirmed DCIS who are eligible for breast-conserving surgery and have ordered the DCISionRT test.

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 improve treatment decision-making for patients with DCIS, potentially leading to better personalized care.

How similar studies have performed: Other studies using molecular testing for treatment decision-making in breast cancer have shown promise, indicating that this approach may be beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Scottsdale, Arizona and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions DCISStage 0 Breast CancerDuctal Breast Carcinoma In Situmolecular testingrisk of recurrencetreatment decisiondecision impactpredictive
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.