Actively Recruiting
Radiological and Endocrine/Metabolic/Inflammatory Biomarkers to Identify High-Grade Dysplasia and Invasive Carcinoma in Patients with Pancreatic Intraductal Papillary Mucinous Neoplasms
Led by IRCCS San Raffaele · Updated on 2024-11-26
586
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating biomarkers and imaging methods to better identify high-grade dysplasia and invasive carcinoma in patients with intraductal papillary mucinous neoplasms (IPMN) of the pancreas. This study aims to improve patient selection to reduce overtreatment and distinguish benign IPMNs from those with higher cancer risk by examining endocrine, metabolic, and inflammatory profiles. The study has three main goals: to validate updated international and European guidelines retrospectively, to identify biomarkers in a prospective patient group, and to validate these biomarkers in a new surgical cohort. The study includes three cohorts: a retrospective group of 350 patients with resected IPMN analyzed to validate guideline accuracy; a prospective observational cohort of 186 patients (145 undergoing surgery) to identify biological and imaging biomarkers using MRI and endoscopic ultrasound (EUS); and a third prospective cohort of 50 patients to validate the identified biomarkers. Imaging assessments focus on features such as main pancreatic duct involvement and surrounding tissue characteristics. Patients undergo standard pre-operative MRI and EUS exams within a three-month window. Participants are involved through retrospective data review or prospective enrollment with informed consent. Assessments include clinical, radiological, and biological evaluations, with follow-up to measure endocrine, metabolic, and inflammatory profiles and imaging biomarkers. Outcomes focus on guideline accuracy, biomarker effectiveness in predicting pathology, and comparison of MRI versus EUS accuracy. The study is observational and does not involve investigational treatments, with participation lasting up to 12 months depending on cohort and follow-up schedule.
CONDITIONS
Brief 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...
- Age 18 years or older
- Histologically confirmed IPMN with full pathological data for Cohort A
- Availability of clinical and imaging criteria for surgical resection according to International and European guidelines for Cohort A
- Charlson comorbidity index less than 7 for Cohorts B and C
- Indication for surgery for suspected IPMN for Cohorts B and C
You will not qualify if you...
- Lack of preoperative clinical and radiological data according to the two guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo imaging tests including MRI and endoscopic ultrasound (EUS) to evaluate pancreatic cysts and identify features that indicate risk of malignancy.
1 to 2 visits depending on imaging schedule
Duration - Up to 8 months
Participants who undergo routine care are observed to assess endocrine, metabolic, and inflammatory biomarkers over time in relation to pancreatic cyst progression.
Periodic visits for biomarker assessments during the monitoring period
Trial Site Locations
Total: 1 location
1
San Raffaele Hospital
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
S
Stefano Crippa, MD
P
Paolo Camisa, MD
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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