About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
blood sampling at inclusion, 6 months, 1 year and 2 years. Tumor and intracystic fluid samples are taken only if a biopsy is planned following MRI results.
Other interventionIf the patient agrees to take part in the study, he or she will have a blood sample taken from 8 x 4 ml EDTA tubes at the time of inclusion in the trial.Then, at 6 months (+/- 1 month), 1 year and 2 years, the patient will have the same blood sample as at inclusion.If a biopsy is performed as part of routine care, a tumor sample will be taken and sent to the IPC pathology department for FFPE block. If a biopsy is performed and the patient consents, a cystic fluid sample will be taken.
Treatment groups
Trial 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.
Biomarkers will be studied to determine whether those selected have been effective in identifying patients with pancreatic adenocarcinoma.
Locations
Sponsors and contacts
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