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Recruiting

Identification of New Theranostic Biomarkers of Pancreatic Tumor Progression

NCT06574373 · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
In plain English

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Official title
New Theranostic Biomarkers of Intraductal Mucinous Neoplasm (IPMN) Progression to Pancreatic Cancer for Patients' Outcome Improvement
About this study
\*\*AIM1.\*\* 1. \*\*Identification\*\* of genes and biological pathways associated with IPMN malignant transformation. The investigators aim to explore the molecular dynamics of tumor progression, focusing on cellular heterogeneity and phenotypic transitions. 2. \*\*Characterization of the microenvironment\*\* to understand its role in IPMN progression. The investigators will collect archival samples from 240 patients across four centers. 3. \*\*Identification and validation in plasma\*\* of selected patients of differentially expressed markers in indolent IPMN, invasive IPMN, and PDAC. \*\*AIM2.\*\* The investigators will develop knowledge-based tools for diagnosing and treating IPMN and at-risk populations. \*\*AIM3.\*\* The investigators will validate the role of key genes in IPMN carcinogenesis using in vitro study models.
Eligibility 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.
Study design
Enrollment target: 3600 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-05-29
Estimated completion: 2026-12-31
Last updated: 2025-09-03
Interventions
Other: Blood Collection Protocol for Patients with Indolent, Invasive, and Pancreatic Cancer-Associated IPMN Based on Clinical Course and Surgical Intervention
Primary outcomes
  • Association of IPMNs tumorigenic progression with a molecular profile (2 years)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · other
With: Azienda Ospedaliera Universitaria Integrata Verona, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, University of Messina
Contacts & investigators
ContactCarmine Carbone, PhD · contact · carmine.carbone@policlinicogemelli.it · 0630155894
InvestigatorCarmine Carbone, PhD · principal_investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
All locations (2)
Fondazione Policlinico GemelliRecruiting
Roma, Italy
IRCCS Fondazione Policlinico Universitario A. GemelliNot Yet Recruiting
Rome, Italy
Identification of New Theranostic Biomarkers of Pancreatic Tumor Progression · TrialPath