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Utility of ctDNA in Early Switch of First-line Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma

StatusRecruiting
PhasePhase 2
Started2025-09-09
View on ClinicalTrials.gov ↗

Amendment history

2025-09-17
Study Status v2
Primary completion date2030-11-01→2030-09-30
Completion date2030-11-01→2030-09-30
Start dateestimated 2025-11-01→confirmed 2025-09-09
2025-09-02
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Design, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2030-10-01→2030-11-01
Completion date2030-10-01→2030-11-01
Start date2025-10-01→2025-11-01
Secondary endpointsdetails revised at 1 of 3 entries
Study sitesdetails revised at 1 of 1 site
2025-07-24
Original filing
The purpose of this study is to understand whether a blood-based test called circulating tumor DNA (ctDNA) can detect whether participants are having a desired tumor shrinkage or an undesired lack of tumor shrinkage, and to study whether these levels of ctDNA can be used to make treatment decisions faster than the current standard approach, which is to wait 8 weeks after starting chemotherapy to obtain participant first imaging scans since starting chemotherapy.
Trial Details
NCT Number NCT07096362
Lead Sponsor University of Miami
Collaborators: National Cancer Institute (NCI), BillionToOne Inc.
Conditions Metastatic Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
Enrollment 50 participants
Start Date 2025-09-09
Primary Completion 2030-09-30 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-21