RecruitingNCT06706700

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

Definition of Radiological and Endocrine/metabolic/inflammatory Biomarker(s) to Identify Highgrade Dysplasia/invasive Carcinoma in Patients with Intraductal Papillary Mucinous Neoplasms of the Pancreas


Sponsor

IRCCS San Raffaele

Enrollment

586 participants

Start Date

Jul 13, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether certain blood markers (hormones, metabolism, and inflammation markers) can predict which patients with a type of pancreatic cyst called an IPMN (intraductal papillary mucinous neoplasm) have developed or are at high risk of developing cancer, helping doctors decide who needs surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with an IPMN of the pancreas - You are either undergoing or have undergone surgery for suspected IPMN, or are being monitored (surveilled) for it - You have relevant clinical and imaging data available **You may NOT be eligible if...** - Your pre-surgical imaging or clinical data is incomplete - You have a high burden of other serious illnesses (Charlson comorbidity index ≥7 in some groups) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

San Raffaele Hospital

Milan, Italy, Italy

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NCT06706700


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