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NCT06706700: EMI-IPMN

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

Recruiting now Last updated 26 November 2024
What this trial tests

trial in Intraductal Papillary Mucinous Neoplasm of Pancreas in 586 participants. Currently enrolling.

Timeline
13 July 2020
Primary endpoint
31 January 2025
31 March 2025

Quick facts

Lead sponsorIRCCS San Raffaele
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment586
Start date13 July 2020
Primary completion31 January 2025
Estimated completion31 March 2025
Sites1 location across Italy

Conditions studied

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

18 and older, any sex, with Intraductal Papillary Mucinous Neoplasm of Pancreas or Pancreatic Cyst. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An oncogenic KRAS-driven secretome involving TNFα promotes niche preparation prior to pancreatic cancer onset.
    Allgöwer C, Mulaw MA, Nagai J, Wiedenmann S, et al · · 2026 · cited 1× · PMID 41634803 · DOI 10.1186/s12943-025-02541-1
  2. UEG Week 2025 Oral Presentations
    · 2025

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06706700.

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