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

Primary Purpose

PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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.

About this trial

This is an interventional other trial for PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

collection of blood and tumor samples

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT06000553

First Posted

June 13, 2023

Last Updated

August 17, 2023

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT06000553

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 30, 2023 (Anticipated)

Primary Completion Date

October 30, 2028 (Anticipated)

Study Completion Date

October 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

the patient takes specific blood samples for the study

Masking

None (Open Label)

Allocation

N/A

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

collection of blood and tumor samples

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

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 Description

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.

Primary Outcome Measure Information:

Title

Description

Biomarkers will be studied to determine whether those selected have been effective in identifying patients with pancreatic adenocarcinoma.

Time Frame

for two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominique GENRE, MD

Phone

049122

drci.up@ipc.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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