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NCT07096362 · ClinicalTrials.gov registry record · Phase 2
Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 2 study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by University of Miami.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07096362: Recruiting Phase 2 study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by University of Miami.
NCT07096362 is a Phase 2 study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by University of Miami. The registered enrollment target is 50 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07096362, a Phase 2 study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Circulating tumor Deoxyribonucleic Acid (ctDNA) fold-change at week 4 is defined as the ratio between ctDNA quantity at week 4 relative to baseline. The quantity of ctDNA will be measured in ng/mL. At week 4 among participants in Part 1 will be reported as a Tumor Methylation Score (TMS) in plasma samples. The ratio between the TMS at week 4 (TMS4) and the TMS at baseline (TMS0) will be calculated.
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Gemcitabine
- DRUG Irinotecan
- DRUG 5-Fluorouracil
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-09-09 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 2 |
What NCT07096362 shows while recruiting
NCT07096362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.
NCT07096362 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07096362 about?
NCT07096362 is a clinical study titled "Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma". 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 ...
What is the current status of trial NCT07096362?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2025-09-09. Estimated completion is 2030-09-30.
What conditions does trial NCT07096362 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT07096362?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Gemcitabine (DRUG), Irinotecan (DRUG), 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT07096362?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07096362 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07096362's enrollment target sits among peer trials
50 58th of 84 higher than 27 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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