Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas PCS-IPMN-IPC 2023-005
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS
- Sponsor
- Institut Paoli-Calmettes
- Enrollment
- 360
- Primary Endpoint
- the aim is to search for immune and metabolic abnormalities in patients with at-risk TIPMP in the blood or by echo-endoscopic sampling, then compare and combine them with the criteria used in clinical practice.
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This trial is a prospective, exploratory and descriptive study. The primary objective is to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to characterize the biological processes underlying the transformation of a pre-neoplastic lesion into established ADPC.
Detailed Description
To meet the objectives of the study, patients will have blood samples taken at the time of their TIPMP monitoring, i.e. at inclusion, 6 months, 1 year and 2 years. If echo-endoscopy is performed during MRI monitoring of their disease, and a sample is taken as part of the treatment, a tumor sample and an intra-cystic fluid sample will be collected as part of the protocol.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age over 18
- •Patient with intermediate-risk or high-risk TIPMP according to the European Study Group on Cystic Tumours of the Pancreas (3)
- •Signed consent to participate
- •Affiliation with a social security scheme, or beneficiary of such a scheme.
Exclusion Criteria
- •Pregnant or breast-feeding woman
- •Person in an emergency situation or unable to give consent.
- •Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
- •Unable to undergo medical follow-up for geographical, social or psychological reasons.
- •contraindication to MRI.
Outcomes
Primary Outcomes
the aim is to search for immune and metabolic abnormalities in patients with at-risk TIPMP in the blood or by echo-endoscopic sampling, then compare and combine them with the criteria used in clinical practice.
Time Frame: for two years
Biomarkers will be studied to determine whether those selected have been effective in identifying patients with pancreatic adenocarcinoma.