Actively Recruiting
Endocrine, Metabolic, Inflammatory Biomarkers to Identify Highgrade Dysplasia/invasive Carcinoma in Patients with IPMN of the Pancreas
Led by IRCCS San Raffaele · Updated on 2024-11-26
586
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Endocrine, Metabolic, Inflammatory Biomarkers to Identify Highgrade Dysplasia/invasive Carcinoma in Patients with IPMN of the Pancreas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed IPMN with complete pathological data
- Clinical and imaging data available for surgical criteria per International and European guidelines
- Age 18 years or older
- Charlson comorbidity index less than 7
- Indication for surgery due to suspected IPMN
You will not qualify if you...
- Missing preoperative clinical or radiological data required by the guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
San Raffaele Hospital
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
S
Stefano Crippa, MD
CONTACT
P
Paolo Camisa, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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