| NCT ID | NCT03448926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PreludeDx |
| Condition | DCIS |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2018-02-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2018-02-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Troy Bremer, PhD
PRINCIPAL INVESTIGATOR
PreludeDx
Frequently Asked Questions
Who can join the NCT03448926 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 85 Years, studying DCIS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03448926 currently recruiting?
Yes, NCT03448926 is actively recruiting participants. Contact the research team at sshivers@preludedx.com for enrollment information.
Where is the NCT03448926 trial being conducted?
This trial is being conducted at Scottsdale, United States, La Jolla, United States, San Mateo, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT03448926 clinical trial?
NCT03448926 is sponsored by PreludeDx. The principal investigator is Troy Bremer, PhD at PreludeDx. The trial plans to enroll 3,000 participants.