New biomarkers to predict which pancreatic IPMNs will progress
Official title: New Theranostic Biomarkers of Intraductal Mucinous Neoplasm (IPMN) Progression to Pancreatic Cancer for Patients' Outcome Improvement
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06574373 · Data updated 2026-11-12
This project will test whether tissue and blood biomarkers can help predict which adults with IPMN will progress to invasive pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3600 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Roma and 1 other locations) |
| Status | Recruiting |
| Started | May 29, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT06574373 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (18+) with an indolent IPMN under surveillance, patients with malignant IPMN, or those with resectable pancreatic adenocarcinoma associated with IPMN who can provide informed consent.
✕Probably not a fit
Patients without IPMN, those with advanced or previously treated metastatic pancreatic cancer, or anyone unable to provide informed consent are unlikely to benefit directly from this observational program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The investigators will analyze tumor tissue, the tumor microenvironment, and blood samples from indolent and invasive IPMN cases and associated pancreatic cancers collected across multiple Italian centers. They will use genomic and molecular profiling to identify genes, pathways, and cellular phenotypes linked to malignant transformation and to characterize cellular heterogeneity. Selected differentially expressed markers will be tested for detectability in plasma and validated in vitro to confirm roles in carcinogenesis. The observational work aims to generate knowledge-based tools to improve diagnosis and management of patients at risk for progression.
Why it matters
Potential benefit: If successful, this work could allow earlier and more accurate identification of high-risk IPMNs so clinicians can better target surgery and surveillance.
How similar studies have gone: Prior biomarker studies in pancreatic cancer and small IPMN cohorts have produced promising candidates, but comprehensive multicenter validation of theranostic markers for IPMN progression is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of indolent IPMN under monitoring; * Diagnosis of malignant IPMN or resectable pancreatic adenocarcinoma with associated IPMN (previously untreated); Written informed consent; Male and female patients aged 18 years or older; Exclusion Criteria: -Inability to provide written informed consent or to trace patients for the retrospective study.
Where it's running
-
Fondazione Policlinico Gemelli
Roma, Italy Recruiting -
IRCCS Fondazione Policlinico Universitario A. Gemelli
Rome, Italy Not yet recruiting
Study contacts
- Principal investigator: Carmine Carbone, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Carmine Carbone, PhD
- Email: carmine.carbone@policlinicogemelli.it
- Phone: 0630155894
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.