Feasibility of Molecular Biology in Pancreatic Cyst Tumors (CYST-GEN)

April 13, 2022 updated by: Arthur Laquiere, Hospital St. Joseph, Marseille, France

Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.

The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.

The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Multicenter study to determinate the feasibility of intra-cystic fluid DNA molecular analysis in patients with suspected cystic tumours of pancreas in whom EUS FNA is clinically indicated.

Morphological criteria obtained by MRI and computerised tomography (tumor characterization (size, metastases presence, dilatation of bile ducts), etiologic diagnosis, serious symptoms), biological exams (biomarkers), cytological analysis will lead to a diagnosis and a treatment.

The goal of this study is to compare this standard diagnostic modalities to diagnosis obtained by intra-cystic fluid DNA molecular analysis.

Is the DNA molecular analysis improve the diagnosis accuracy.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Charenton-le-Pont, France, 94220
        • Clinique de Bercy
      • Limoges, France, 87000
        • Centre Hospitalier Universitaire Dupuytren
      • Lyon, France, 69003
        • Hopital Edouard Herriot
      • Lyon, France, 69008
        • Hopital Mermoz
      • Marseille, France, 13385
        • CHU La Timone
      • Marseille, France, 13003
        • Hopital Europeen
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Nantes, France, 44000
        • CHU NANTES Institut des Maladies de l'Appareil Digestif
      • Nice, France, 06200
        • Chu L'Archet 2
      • Paris, France, 75014
        • Hopital Saint Joseph
      • Vichy, France, 03207
        • Centre Hospitalier Jacques Lacarin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient older than 18 years of age, male or female
  • Cystic tumor of the pancreas requiring a puncture under endoscopic control to determine the etiologic diagnosis and gravity.

Exclusion Criteria:

  • Doubts regarding the etiological diagnosis of the pancreatic cyst
  • Contraindications for the realization of a high digestive endoscopy
  • Haemorrhagic disorder, haemostasis and coagulation disorder (TP <60%, TCa> 40 sec and platelets <60000 / mm3).
  • AVK, AOD and AAP cannot be stopped

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm

For inoperable patients with indeterminate cystic lesions of the pancreas,a EUS FNA will be performed and molecular biology analysis of pancreatic intra-cyst fluid collected by EUS FNA will be performed.

For operable patients, after the pancreatic surgery, molecular biology analysis of extemporaneous pancreatic tissue specimen biopsy will be conducted.
Genetic: Molecular biology analysis of pancreatic intra-cyst fluid

The EUS FNA will be performed according to the Francophone Club of Echo Endoscopy recommendations.

For molecular biology technique, the samples will be processed within the UMR_S910 unit. Nucleic acids will be extracted from the intra-cystic fluid or, for post-operative patients, from a resected specimen that will be collected into a tube containing a nucleic acid stabilization solution (Allprotect Tissue reagent, Qiagen).

The nucleic acids will be extracted and then sequenced. The sequencing technology chosen (HaloPlexHS, Agilent) allows a detection close to 1% in allelic frequency. This new technical approach that links high sensitivity and specificity is also suitable with degraded and/or low-volume ( <50ng) DNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen
Time Frame: 10 days
The nucleic acids of the samples will be extracted and then sequenced on a panel of about 70 genes implicated in the pancreatic tumorigenesis and targeting RAS, MAPK, AKT, JAK-STAT, WNT, TGFB, TP53 and Repair BRCA, ATM. The selected sequencing technology (HaloPlexHS ®, Agilent) will be used. A comparison of the molecular profiles between the cystic fluid and the surgical specimen will be carried out and then confronted with the pathology, biological, radiological and clinical characterization
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility of the molecular biology analysis of the pancreatic cystic tumor fluid to distinguish the pancreatic cysts.
Time Frame: up to 6 months
The nucleic acids of the samples will be extracted from the different cyst fluids and then sequenced. A comparison of the molecular profiles between the different cystic fluids will be carried out and then confronted with the pathology, biological, radiological and clinical characterization
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital St. Joseph, Marseille, France

Collaborators

Ramsay Générale de Santé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 9, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01399-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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