Identifying cancer risk in patients with pancreatic cysts
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
This study is testing if better ways to identify cancer risk in patients with pancreatic cysts can help avoid unnecessary treatments and improve outcomes for those with these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 586 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06706700 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the identification of high-grade dysplasia and invasive carcinoma in patients with intraductal papillary mucinous neoplasms (IPMN) of the pancreas. It will evaluate the accuracy of existing international and European guidelines for managing IPMN by analyzing data from 350 patients with resected IPMN. Additionally, the study will prospectively identify biological and radiological biomarkers that can distinguish low-risk from high-risk IPMN for cancer progression in a cohort of 186 patients. The goal is to reduce overtreatment of benign IPMNs and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically proven IPMNs and complete pathological data.
Not a fit: Patients lacking preoperative clinical and radiological data according to the guidelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate identification of patients at risk for pancreatic cancer, reducing unnecessary surgeries and associated complications.
How similar studies have performed: While there have been studies focusing on biomarkers for pancreatic cancer, this approach of using endocrine, metabolic, and inflammatory profiles to distinguish between benign and malignant IPMNs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
cohort A: 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 exclusion criteria: \- lack of preoperative clinical and radiological data according the two guidelines Cohort B and C: inclusion criteria: * Age \>= 18 years * Charlson comorbidity index \<7 * indication for surgery for suspected IPMN
Where this trial is running
Milan, Italy
- San Raffaele Hospital — Milan, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Crippa, MD
- Email: crippa.stefano@hsr.it
- Phone: +39 0226437811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.