New biomarkers to predict which pancreatic IPMNs will progress
New Theranostic Biomarkers of Intraductal Mucinous Neoplasm (IPMN) Progression to Pancreatic Cancer for Patients' Outcome Improvement
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 |
|---|---|
| Enrollment | 3600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Roma and 1 other locations) |
| Trial ID | NCT06574373 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma and 1 other locations
- 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
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.