NCT06706700 Endocrine, Metabolic, Inflammatory Biomarkers to Identify Highgrade Dysplasia/invasive Carcinoma in Patients with IPMN of the Pancreas
| NCT ID | NCT06706700 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Intraductal Papillary Mucinous Neoplasm of Pancreas |
| Study Type | OBSERVATIONAL |
| Enrollment | 586 participants |
| Start Date | 2020-07-13 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 586 participants in total. It began in 2020-07-13 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06706700 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intraductal Papillary Mucinous Neoplasm of Pancreas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06706700 currently recruiting?
Yes, NCT06706700 is actively recruiting participants. Contact the research team at crippa.stefano@hsr.it for enrollment information.
Where is the NCT06706700 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06706700 clinical trial?
NCT06706700 is sponsored by IRCCS San Raffaele. The trial plans to enroll 586 participants.