PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Medical College of Wisconsin
- Study ID
- NCT04683315
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- mFOLFIRINOX Treatment Regimen — DRUGThis therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
- Gemcitabine/Nab-paclitaxel Treatment Regimen — DRUGThis regimen will be nab-paclitaxel and gemcitabine.
Study Details
This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.
Key Dates
- Start date
- Apr 1, 2021
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 84 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Subtype diagnosis and classification: BasalPatients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Upon diagnosis, patients categorized as basal will receive two months of the Gemcitabine/Nab-paclitaxel Treatment Regimen.
- Experimental: Subtype diagnosis and classification: ClassicalPatients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Patients in the classical group will receive two months of the mFOLFIRINOX Treatment Regimen.
Primary Outcome Measure
Subjects who receive PurIST classification-directed therapy. [ Time Frame: 12 weeks ]
Central Contacts
- Medical College of Wisconsin Cancer Center Clinical Trials Office866-680-0505
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| HonorHealth Medical Group | Scottsdale | Arizona | 85258-4566 | Gayle Jameson, APNP 480-323-1350 |
| Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 |
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