Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas

Institut Paoli-Calmettes

Status: Not yet enrolling

Conditions: PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS

Treatments: Other: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT06000553

PCS-IPMN-IPC 2023-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age over 18
2. Patient with intermediate-risk or high-risk TIPMP according to the European Study Group on Cystic Tumours of the Pancreas (3)
3. Signed consent to participate
4. Affiliation with a social security scheme, or beneficiary of such a scheme.

Exclusion criteria

1. Pregnant or breast-feeding woman
2. Person in an emergency situation or unable to give consent.
3. Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
4. Unable to undergo medical follow-up for geographical, social or psychological reasons.
5. contraindication to MRI.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 1 patient group

collection of blood and tumor samples

Other group

Treatment:

Other: 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.