Prediction of Neoadjuvant Chemotherapy Response in Pancreatic Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07226154
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Small RNA sequencing — DIAGNOSTIC_TEST
    High-throughput small RNA sequencing performed on pre-treatment plasma samples from PDAC patients in the Discovery cohort to identify candidate microRNAs associated with neoadjuvant chemotherapy response. Sequencing data were analyzed to detect differentially expressed miRNAs between responder (CR + PR + SD) and non-responder (PD) groups.
  • PRECEPT assay (qRT-PCR validation) — DIAGNOSTIC_TEST
    Quantitative reverse transcription PCR (qRT-PCR)-based validation assay performed on pre-treatment plasma samples in the Training and Validation cohorts. Candidate microRNAs identified in the Discovery cohort by small RNA sequencing were tested using the PRECEPT assay to develop and validate a predictive miRNA panel for neoadjuvant chemotherapy response.

Study Details

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).

Key Dates

Start date
Nov 15, 2024
Status verified
Nov 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Pathological Response Rate [ Time Frame: up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91016
Ajay Goel, PhD
[email protected]
626-218-3452

Find similar trials in Duarte, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
City of Hope Medical Center· Duarte, CA

Related Studies