Recruiting

miRNA Panel

Sponsor:

City of Hope Medical Center

Code:

NCT07226154

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Small RNA sequencing

PRECEPT assay (qRT-PCR validation)

Study Details

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).

Conditions

Pancreatic Ductal Adenocarcinoma

Study ID

NCT07226154

Start date

Nov 15, 2024

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Small RNA sequencing

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)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91016

Contacts

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • PDAC
  • Exosome
  • miRNA
  • FOLFIRINOX
  • gemcitabine plus nab-paclitaxel
  • neoadjuvant chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-19.