CYST-GEN: Feasibility of Molecular Biology in Pancreatic Cyst Tumors

Sponsor

Hospital St. Joseph, Marseille, France (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03305146

Collaborator

Ramsay Générale de Santé (Other)

Enrollment

Locations

Arm

120

Anticipated Duration (Months)

8.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cyst Pancreas Cyst Serous Cystadenoma Mucinous Cystadenoma IPMN	Genetic: Molecular biology analysis of pancreatic intra-cyst fluid	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

93 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

First 20 patients for pilot study to test the feasibility of the molecular analysis then 120 patients to continue the trial.First 20 patients for pilot study to test the feasibility of the molecular analysis then 120 patients to continue the trial.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen [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

Secondary Outcome Measures

Evaluate the feasibility of the molecular biology analysis of the pancreatic cystic tumor fluid to distinguish the pancreatic cysts. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique de Bercy	Charenton-le-Pont	France	94220
2	Centre Hospitalier Universitaire Dupuytren	Limoges	France	87000
3	Hopital Edouard Herriot	Lyon	France	69003
4	Hopital Mermoz	Lyon	France	69008
5	Hopital Europeen	Marseille	France	13003
6	Hopital Saint Joseph	Marseille	France	13008
7	Chu La Timone	Marseille	France	13385
8	CHU NANTES Institut des Maladies de l'Appareil Digestif	Nantes	France	44000
9	Chu L'Archet 2	Nice	France	06200
10	Hopital Saint Joseph	Paris	France	75014
11	Centre Hospitalier Jacques Lacarin	Vichy	France	03207

Sponsors and Collaborators

Hospital St. Joseph, Marseille, France
Ramsay Générale de Santé

Investigators

Principal Investigator: Arthur Laquière, MD, French Society of Digestive Endoscopy

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Arthur Laquiere, Principal Investigator Dr Arthur LAQUIERE, Hospital St. Joseph, Marseille, France

ClinicalTrials.gov Identifier:

NCT03305146

Other Study ID Numbers:

2016-A01399-42

First Posted:

Oct 9, 2017

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cysts

Pancreatic Cyst

Cystadenoma

Cystadenoma, Mucinous

Cystadenoma, Serous

Study Results

No Results Posted as of Apr 14, 2022