Integration of Multiomics Markers for Invasive IPMNs Identification Through the Set-up of the INvasive Cyst bIomarkers Detection (INCITE) Consortium

NCT06694792 | Recruiting

• 1 other identifier: INCITE
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Although intraductal papillary mucinous neoplasms (IPMNs) represent potential precursors of pancreatic cancer, IPMNs with invasive cancer are rare. Based on current risk factors for malignancy, overtreatment (surgery) of benign IPMNs remains a critical issue, with its associated risk of postoperative and long-term complications. Identification of biomarkers that could predict malignancy in IPMNs is an unmet clinical need. Environmental, lifestyle, genetics and metabolic factors may play a role in IPMNs carcinogenesis. Aims of the study are: 1) to analyze exposome, somatic/germline genetic variability, metabolomics and transcriptome profile in order to identify new biomarkers; 2) to use nonparametric epidemiologic approaches and machine learning algorithms to compute a progression score to offer clinicians an innovative tool towards the goal of a personalized medicine approach. In order to perform all the analysis we will set up the Invasive Cyst biomarker detection (INCITE) consortium, between the participant centers in order to collectively enroll an adequate number of patients to fulfill the previous aims. The project is designed as an observational cross-sectional multicenter study with additional procedures. The analysis will be conducted on biological samples collected at a single time point. Some samples (500 patients: 160 surgical, 340 under surveillance) are already available in the consortium, having been collected in previous studies, while additional 300 (100 surgical and 200 under surveillance) patients will be prospectively enrolled during the first 12 months of the study. The sample collection will take place during outpatient visit/EUS procedure for the surveillance cohort, while in the surgical cohort all the material will be retrieved during the surgery. The patients samples will be divided in two cohorts, the first will be a discovery cohort and the second one a validation cohort. The first cohort will consist in patients already collected. The validation cohort will include patients enrolled prospectively during the first year of the study.

Conditions

IPMN, Pancreatic

Keywords

IPMN; pancreatic disease; multiomics markers

Outcome Measures

Primary Outcomes (1)

• Analyzing exposome, metabolomics and transcriptome profile

  Exposome data will be analyzed for all the patients enrolled in the study (global exposure to different external and internal agents). Metabolomics. The metabolic/inflammatory profile of IPMNs will be analyzed in order to identify specific signatures associated with malignancy using cyst fluid collected from IPMNs during pancreatectomy and peripheral blood. Analytes will be measured as pg/mL. The transcriptome profiling of microdissected enriched formalin-fixed, paraffin-embedded (FFPE) samples from IPMN tissue specimens compared to non-pathological counterparts (specimens of normal tissue adjacent to the lesion or peripheral blood), assessed by an expert pathology, and of cyst fluid samples (where available) will be dissected by using whole transcriptome sequencing (RNA-seq) approach. The RNA data will be analysed as TPM (Transcripts Per Kilobase Million).

  All procedures on the patients will be carried out during their hospital stay for surgical patients and during the EUS procedure for the surveillance cohort.

Study Arms (2)

discover cohort

The discover cohort will consist in patients already collected

Validation cohort

The validation cohort will include patients enrolled prospectively during the first year of the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with diagnosis of IPMN

You may qualify if:

• 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

You may not qualify if:

• Patients \< 18 years of age
• Patients who are not able to supply an informed consent

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• University of Pisa: collaborator
• Casa Sollievo della Sofferenza IRCCS: collaborator
• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: collaborator

Study Sites (1)

San Raffaele Hospital

Milan, MI, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample and cystic liquid

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases

Central Study Contacts

Stefano Crippa, MD

CONTACT

+390226436046; crippa.stefano@hsr.it

Gabriele Capurso, MD

CONTACT

+390226436046; capurso.gabriele@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 19, 2024
• Study Start: January 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

IT (1)