Using multi-omics markers to find invasive IPMNs
Official title: Integration of Multiomics Markers for Invasive IPMNs Identification Through the Set-up of the INvasive Cyst bIomarkers Detection (INCITE) Consortium
Run by IRCCS San Raffaele · NCT06694792 · Data updated 2026-11-12
This project tests whether combining genetic, metabolic, transcriptomic and environmental markers can help identify which adults with IPMNs have or will develop invasive pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | January 3, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT06694792 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age >18) with a clinical or pathologic diagnosis of IPMN who can give informed consent, including patients both undergoing and not undergoing surgery, are eligible.
✕Probably not a fit
Patients under 18, those unable to consent, and individuals whose IPMNs have already been definitively resected and characterized pathologically are unlikely to benefit directly from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The INCITE consortium will collect clinical data and biological samples from adults with intraductal papillary mucinous neoplasms (IPMNs) and apply multi-omics profiling (exposome, germline/somatic genetics, metabolomics, transcriptomics). Retrospective and prospective samples will be analyzed and integrated using nonparametric epidemiologic methods and machine learning to produce a progression score. The goal is to improve identification of IPMNs that harbor high-grade dysplasia or invasive cancer and reduce unnecessary surgeries driven by current imprecise criteria. The consortium model centralizes data and biomaterials across multiple Italian centers to enable larger-scale biomarker discovery and validation.
Why it matters
Potential benefit: If successful, the approach could help doctors better distinguish benign from malignant IPMNs, reducing unnecessary pancreatectomies and focusing surgery on patients who need it.
How similar studies have gone: Smaller studies of individual genomic or molecular markers in IPMN have shown promising signals, but no validated multi-omics prediction tool for malignancy has been established yet.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age \>18 years) patients with a diagnosis of IPMN undergoing and not undergoing surgery * All patients will sign the informed consent For the retrospective patients: * confirmed IPMN diagnosis * signed informed consent for samples biobanking and study participation Exclusion Criteria: * Patients \< 18 years of age * Patients who are not able to supply an informed consent
Where it's running
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San Raffaele Hospital
Milan, Mi, Italy Recruiting
Study contacts
- Study coordinator: Stefano Crippa, MD
- Email: crippa.stefano@hsr.it
- Phone: +390226436046
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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.