An Exosomal miRNA Based Predictive Model for Personalized Neoadjuvant Chemotherapy Selection in Pancreatic Ductal Adenocarcinoma

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Contact Information
Primary
Ajay Goel, PhD
ajgoel@coh.org
626-218-3452
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2026-06-18
Participants
Target number of participants: 200
Treatments
Discovery Cohort - NAC Responder Group
Patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC) who received neoadjuvant chemotherapy (FOLFIRINOX or gemcitabine plus nab-paclitaxel) and achieved a clinical or pathological response.~Responders were defined as patients showing complete response (CR), partial response (PR), or stable disease (SD) according to radiologic or pathologic assessment after NACT.~Pre-treatment plasma samples from these patients were analyzed by small RNA sequencing to identify microRNAs associated with favorable chemotherapy response.
Discovery Cohort - NAC Non-Responder Group
Patients with resectable or borderline resectable PDAC who received neoadjuvant chemotherapy but demonstrated progressive disease (PD) on radiologic or pathologic evaluation.~Pre-treatment plasma samples from these patients were analyzed in parallel by small RNA sequencing to identify differential miRNA expression compared with responders.
Training Cohort - NAC Responder Group
PDAC patients treated with neoadjuvant chemotherapy (FOLFIRINOX or gemcitabine plus nab-paclitaxel) who achieved CR, PR, or SD responses.~Candidate microRNAs identified in the Discovery cohort were validated using qRT-PCR (PRECEPT assay).~Responder group data were used to train and optimize the predictive miRNA panel.
Training Cohort - NAC Non-Responder Group
PDAC patients who received neoadjuvant chemotherapy but exhibited progressive disease (PD).~Plasma miRNA expression was measured using the PRECEPT assay and compared with responders to refine the predictive model for chemotherapy response.
Validation Cohort - NAC Responder Group
A separate validation cohort of PDAC patients treated with neoadjuvant chemotherapy who achieved CR, PR, or SD.~The established PRECEPT miRNA panel (qRT-PCR) was applied to evaluate predictive accuracy in this independent responder group.
Validation Cohort - NAC Non-Responder Group
Independent PDAC patients who received neoadjuvant chemotherapy and demonstrated progressive disease (PD).~This cohort was used to confirm the predictive performance and robustness of the PRECEPT miRNA assay compared with responders.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center

This content was sourced from clinicaltrials.gov