NCT03305146

Feasibility of Molecular Biology in Pancreatic Cyst Tumors

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Hospital St. Joseph, Marseille, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cyst
• Pancreas Cyst
• Serous Cystadenoma
• Mucinous Cystadenoma
• IPMN

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-12-01
• Completion: 2027-01-01
• First posted: 2017-10-09
• Last updated: 2022-04-14

Locations

11 sites across 1 country: France