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

NCT ID: NCT06000553

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2028-10-30

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.

Conditions

PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

collection of blood and tumor samples

Group Type: 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.

Intervention Type: OTHER

If 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.

Interventions

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.

If 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dominique GENRE, MD

Role: CONTACT

drci.up@ipc.unicancer.fr

049122

Other Identifiers

PCS-IPMN-IPC 2023-005

Identifier Type: -

Identifier Source: org_study_id