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Recruiting NCT07226154

Prediction of Neoadjuvant Chemotherapy Response in Pancreatic Cancer

Trial Parameters

Condition Pancreatic Ductal Adenocarcinoma
Sponsor City of Hope Medical Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-15
Completion 2026-06-18
Interventions
Small RNA sequencingPRECEPT assay (qRT-PCR validation)

Brief Summary

This study aims to develop and validate a predictive microRNA (miRNA) panel to assess the response to neoadjuvant chemotherapy (NACT) in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC).

Eligibility Criteria

Inclusion Criteria: * Histologically confirmed pancreatic ductal adenocarcinoma (PDAC). * Underwent neoadjuvant chemotherapy (FOLFIRINOX or Gemcitabine/nab-paclitaxel). * Availability of pre-treatment plasma samples. * Underwent curative-intent resection (R0 or R1). Exclusion Criteria: * Inadequate plasma samples or poor RNA quality for exosomal miRNA analysis. * Non-adenocarcinoma histology. * Presence of synchronous or multiple primary malignancies. * Receipt of chemotherapy regimens other than standard FOLFIRINOX or gemcitabine plus nab-paclitaxel (GEM-NABP). * Presence of active inflammatory or autoimmune diseases.

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