Finding blood-measurable protein and metabolite markers for pancreatic cancer using biopsy rinse samples
Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology (PanEXPEL2)
This project will try whether proteins and small molecules recovered from the fluid used to rinse fine-needle biopsy samples can identify pancreatic cancer in people with a suspicious pancreatic mass.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Montpellier, Montpellier) |
| Trial ID | NCT04370574 on ClinicalTrials.gov |
What this trial studies
Researchers will prospectively collect the CytoLyt® rinse fluid from endoscopic ultrasound fine-needle aspiration (EUS/FNA) samples and separate patients into PDAC and non-PDAC groups based on final biopsy diagnosis. The modified EXPEL (PANEXPEL) procedure will process fluid that is normally discarded to extract proteins and metabolites for quantitative proteomic and metabolomic analysis. Candidate diagnostic markers will be identified using ROC/AUC and related metrics and validated by immunohistochemistry and targeted mass spectrometry (multiple reaction monitoring), while prognostic markers will be tested with 1-year survival curves and Cox regression. The overall aim is to define a combined protein/metabolite signature that can later be measured noninvasively in patient blood using routine clinical methods.
Who should consider this trial
Good fit: Adults with a pancreatic mass who are scheduled for endoscopic ultrasound with fine-needle biopsy because clinicians suspect pancreatic ductal adenocarcinoma and who can give informed consent (non-pregnant).
Not a fit: People without a pancreatic mass, those not undergoing EUS/FNA, pregnant women, and legally vulnerable persons (per French regulation) are not eligible and would not receive benefit from participation.
Why it matters
Potential benefit: If successful, this could yield a combined protein/metabolite signature measurable in blood that helps detect or diagnose pancreatic cancer more quickly and less invasively.
How similar studies have performed: The EXPEL concept to recover molecular material from biopsy rinse has been piloted, but applying a prospective PANEXPEL workflow for combined proteomic/metabolomic blood-signature discovery is relatively novel and not yet proven in large cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy Exclusion Criteria: * Vulberable person according to L1121-6 of Public health reglementation in France * Pregnant women
Where this trial is running
Montpellier, Montpellier
- Uh Montpellier — Montpellier, Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Régis SOUCHE, MD
- Email: fr-souche@chu-montpellier.fr
- Phone: +33467337069
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.