Endocrine, Metabolic, Inflammatory Biomarkers to Identify Highgrade Dysplasia/invasive Carcinoma in Patients with IPMN of the Pancreas

NCT06706700 | Recruiting

• 1 other identifier: EMI-IPMN
• Study Type: observational
• Target: 586
• Locations: 1 country
• Sites: 1

Brief Summary

Under the hypotheses that a more accurate patients selection could limit the problem of overtreatment and that benign intraductal papillary mucinous neoplasms (IPMN) have a distinguishable Endocrine/Metabolic/Inflammatory (EMI) profile from those with high-grade disease/invasive carcinoma, this study has three specific aims. The first aim is to evaluate and confirm the accuracy of the updated versions of International and European guidelines for the management of IPMN and it will be addressed by retrospectively applying the criteria included in the two guidelines on 350 patients with resected IPMN in order to determine the most accurate criteria to identify High Grade Dysplasia(HGD)/Invasive Carcinoma (IC). The second aim is to identify pre-operative biological and/or radiological/endosonographic biomarker(s) able to distinguish low- versus high-risk IPMN for cancer progression in a prospective study by enrolling a cohort of 186 (of which 145 surgically-resected) patients. The third aim is to prospectively validate biological and/or radiological/endosonographic biomarker(s) (previously identified and optimized) on a new cohort of 50 patients with IPMN undergoing surgical resection.

Conditions

Intraductal Papillary Mucinous Neoplasm of Pancreas; Pancreatic Cyst

Keywords

ipmn; intraductal papillary mucinous neoplasm of the pancreas; Pancreatic Cysts

Outcome Measures

Primary Outcomes (4)

• evaluation of the best guideline between the International and European guidelines

  The criteria included in the two guidelines will be retrospectively applied on 350 patients with resected IPMN. Clinical pathological and imaging data will be retrieved from institutional archives systems. As we may be not able to identify a more accurate guideline, we may select specific criteria from each of the two guidelines, thus selecting p batients for surgery based on a combination of criteria from both guidelines. The identified best criteria will be applied to select the discovery cohort and the validation cohort of the prospective studies.

  from the collection of the retrospective cohort to 12 months

• endocrine, metabolic and inflammatory profile

  The following parameters will be measured in peripheral and portal serum/plasma and in the cyst fluid with commercially available kits

  from the enrollment to 8 month

• imaging-based biomarker(s)

  As per standard-of-care current clinical practice in our institution, all patients will undergo 1.5T contrast-enhanced MR cholangiopancreatography (MRCP) with 3D acquisition protocol of the pancreatic ducts/ biliary tree

  at the time of enrollment

• evaluation of the accuracy of the biomarkers in predicting the pathological diagnosis

  the accuracy at identifying malignant IPMN of the identified biomarkers will be tested.

  at the end of the enrollment

Secondary Outcomes (1)

• evaluation of the accuracy of the MRI versus the EUSP in identifying the involvement of the main pancreatic duct

  at the end of the enrollment

Study Arms (3)

Cohort A

A retrospective study of a cohort of 350 resected patients with a histologically-confirmed IPMN, diagnosed from the 1st January 2009 to the 31st May 2018 following these inclusion criteria: * histologically proven IPMNs with full pathological data (type of IPMNs, grade of dysplasia; for invasive IPMNs: grading, pTNM classification, presence of perineural (microvascular infiltration) * availability of clinical and imaging criteria for surgical resections defined by International and European guidelines (worrisome features and high-risk stigmata according to International Guidelines and absolute/relative criteria for surgery according to European guidelines * age ≥18 years and exclusion criteria: * lack of preoperative clinical and radiological data according the two guidelines

Cohort B

A prospective observational study whose aim is to identify EMI profiles and radiological/endosonographical biomarker(s) associated to surgically removed IPMNs with HGD/IC. Patients diagnosed with IPMN and candidates for resection with following inclusion criteria will be enrolled: * Age \>= 18 years * Charlson comorbidity index \<7 \[26\] The patients' cohort will be selected following the best criteria for surgery identified in the retrospective study (Cohort A). At the admission, patients will be informed by PI, or his delegates about the study, and they will be asked to sign the specific informed consents (see par. 5.1) In the course of standard pre-operative evaluation, all patients will undergo MRI and EUS, within no more than 3 months between exams.

Cohort C

A prospective study with the aim to validate potential biomarker(s) identified in the Cohort B. Patients with a diagnosis of IPMN candidate for resection with the following inclusion criteria will be enrolled: * Age \>= 18 years * Charlson comorbidity index \<7 \[26\] The patients' cohort will be selected following the best criteria for surgery identified in the retrospective study (Cohort A). At the admission patients will be informed by PI or his delegates about the study and they will be asked to sign specific informed consents

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

The patients will be enrolled in the outpatient clinic, if they meet the required criteria for inclusion.

You may qualify if:

• histologically proven IPMNs with full pathological data (type of IPMNs, grade of dysplasia; for invasive IPMNs: grading, pTNM classification, presence of perineural (microvascular infiltration)
• availability of clinical and imaging criteria for surgical resections defined by International and European guidelines (worrisome features and high-risk stigmata according to International Guidelines and absolute/relative criteria for surgery according to European guidelines
• age ≥18 years

You may not qualify if:

• \- lack of preoperative clinical and radiological data according the two guidelines
• Cohort B and C:
• Age \>= 18 years
• Charlson comorbidity index \<7
• indication for surgery for suspected IPMN

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, Italy, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples from peripheral and portal blood: Serum, Plasma, PBMCs and whole blood will be stored; Cyst Fluid from the pancreatic cyst; Formalin-Fixed Paraffin-Embedded tissue from the Pancreatic Cyst

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms; Pancreatic Cyst

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; Pancreatic Diseases; Endocrine System Diseases; Cysts

Central Study Contacts

Stefano Crippa, MD

CONTACT

+39 0226437811; crippa.stefano@hsr.it

Paolo Camisa, MD

CONTACT

+39 0226436046; camisa.paoloriccardo@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: November 22, 2024
• First Posted: November 26, 2024
• Study Start: July 13, 2020
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)