Feasibility of Molecular Biology in Pancreatic Cyst Tumors (CYST-GEN)
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|ClinicalTrials.gov Identifier: NCT03305146|
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : April 4, 2019
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||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2022|
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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305146
|Contact: Laurence Lecomtefirstname.lastname@example.org|
|Clinique de Bercy||Not yet recruiting|
|Charenton-le-Pont, France, 94220|
|Contact: DAVID KARSENTI, MD|
|Centre Hospitalier Universitaire Dupuytren||Not yet recruiting|
|Limoges, France, 87000|
|Contact: JEREMIE JACQUES, MD|
|Sub-Investigator: ROMAIN LEGROS, MD|
|Sub-Investigator: HUGO PETIT, MD|
|Hopital Edouard Herriot||Not yet recruiting|
|Lyon, France, 69003|
|Contact: MATHIEU PIOCHE, MD|
|Sub-Investigator: FLORIAN ROSTAIN, MD|
|Sub-Investigator: JEROME RIVORY, MD|
|Lyon, France, 69008|
|Contact: BERTRAND NAPOLEON, MD 33478082354 email@example.com|
|Sub-Investigator: BERTRAND FUMEX, MD|
|Sub-Investigator: RODICA GINCUL, MD|
|Sub-Investigator: CHRISTINE LEFORT, MD|
|Marseille, France, 13003|
|Contact: VINCENT VALANTIN, MD 33491907770 firstname.lastname@example.org|
|Sub-Investigator: CLIO LOEVE, MD|
|Sub-Investigator: XAVIER LAGRANGE, MD|
|Sub-Investigator: THIERRY HELBERT, MD|
|Hopital Saint Joseph||Recruiting|
|Marseille, France, 13008|
|Contact: ARTHUR LAQUIERE, MD 33491808207 email@example.com|
|Contact: LAURENCE LECOMTE 33491808207 firstname.lastname@example.org|
|Chu La Timone||Recruiting|
|Marseille, France, 13385|
|Contact: PHILIPPE GRANDVAL, MD 33491388213 email@example.com|
|Sub-Investigator: LAURENT HEYRIES, MD|
|Sub-Investigator: MARINE BARRAUD, MD|
|CHU NANTES Institut des Maladies de l'Appareil Digestif||Not yet recruiting|
|Nantes, France, 44000|
|Contact: EMMANUEL CORON, MD|
|Chu L'Archet 2||Not yet recruiting|
|Nice, France, 06200|
|Contact: GEOFFROY VANBIERVLIETMD|
|Hopital Saint Joseph||Not yet recruiting|
|Paris, France, 75014|
|Contact: YANN LE BALEUR, MD|
|Centre Hospitalier Jacques Lacarin||Not yet recruiting|
|Vichy, France, 03207|
|Contact: JOCELYN PRIVAT, MD|
|Principal Investigator:||Arthur Laquière, MD||French Society of Digestive Endoscopy|