IPMN, Mucinous Cystadenoma, Pancreas Cyst, Pancreatic Cyst, Serous Cystadenoma
Conditions
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.
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.
Interventions
GENETICMolecular 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.
Sponsors
Ramsay Générale de Santé
Hospital St. Joseph, Marseille, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
First 20 patients for pilot study to test the feasibility of the molecular analysis then 120 patients to continue the trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed