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
Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \>= 18 years
• Charlson comorbidity index \<7
• indication for surgery for suspected IPMN
Locations
Other Locations
Italy
San Raffaele Hospital
RECRUITING
Milan
Contact Information
Primary
Stefano Crippa, MD
crippa.stefano@hsr.it
+39 0226437811
Backup
Paolo Camisa, MD
camisa.paoloriccardo@hsr.it
+39 0226436046
Time Frame
Start Date:2020-07-13
Estimated Completion Date:2025-03-31
Participants
Target number of participants:586
Treatments
Cohort A
A retrospective study of a cohort of 350 resected patients with a histologically-confirmed IPMN, diagnosed from the 1st January 2009 to the 31st May 2018 following these 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 and exclusion criteria:~* lack of preoperative clinical and radiological data according the two guidelines
Cohort B
A prospective observational study whose aim is to identify EMI profiles and radiological/endosonographical biomarker(s) associated to surgically removed IPMNs with HGD/IC.~Patients diagnosed with IPMN and candidates for resection with following inclusion criteria will be enrolled:~* Age \>= 18 years~* Charlson comorbidity index \<7 \[26\] The patients' cohort will be selected following the best criteria for surgery identified in the retrospective study (Cohort A).~At the admission, patients will be informed by PI, or his delegates about the study, and they will be asked to sign the specific informed consents (see par. 5.1) In the course of standard pre-operative evaluation, all patients will undergo MRI and EUS, within no more than 3 months between exams.
Cohort C
A prospective study with the aim to validate potential biomarker(s) identified in the Cohort B.~Patients with a diagnosis of IPMN candidate for resection with the following inclusion criteria will be enrolled:~* Age \>= 18 years~* Charlson comorbidity index \<7 \[26\] The patients' cohort will be selected following the best criteria for surgery identified in the retrospective study (Cohort A).~At the admission patients will be informed by PI or his delegates about the study and they will be asked to sign specific informed consents