Predicting chemotherapy response in pancreatic cancer using a blood microRNA panel
An Exosomal miRNA Based Predictive Model for Personalized Neoadjuvant Chemotherapy Selection in Pancreatic Ductal Adenocarcinoma
This project tests whether a panel of microRNAs in pre-treatment blood can predict response to neoadjuvant chemotherapy (FOLFIRINOX or gemcitabine plus nab‑paclitaxel) in patients with resectable or borderline resectable pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07226154 on ClinicalTrials.gov |
What this trial studies
PRECEPT is a retrospective, non-interventional analysis using archived pre-treatment plasma from patients with resectable or borderline resectable pancreatic ductal adenocarcinoma who received neoadjuvant FOLFIRINOX or gemcitabine plus nab‑paclitaxel and subsequently underwent curative-intent surgery. Investigators performed exosomal small RNA sequencing to identify candidate microRNAs and will validate selected candidates by qRT-PCR in an independent cohort. The study will correlate pre-treatment miRNA levels with pathologic response (CAP grade or tumor regression score) and explore associations with overall survival and recurrence-free survival. All analyses are performed on existing biospecimens and clinical records without additional interventions.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed PDAC who had pre-treatment plasma available, received standard neoadjuvant FOLFIRINOX or gemcitabine plus nab‑paclitaxel, and underwent curative-intent resection.
Not a fit: Patients with metastatic disease, non-adenocarcinoma histology, those who received nonstandard chemotherapy regimens, or who lack good-quality pre-treatment plasma samples are unlikely to benefit from this analysis.
Why it matters
Potential benefit: If successful, the miRNA panel could help doctors choose the chemotherapy most likely to work for an individual patient and spare others from ineffective treatment.
How similar studies have performed: Prior small studies and exploratory reports have suggested circulating or exosomal miRNAs can correlate with chemotherapy response in PDAC, but no widely validated predictive miRNA panel currently exists.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: ajgoel@coh.org
- Phone: 626-218-3452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.