Feasibility of Molecular Biology in Pancreatic Cyst Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (11)

More Hospital St. Joseph, Marseille, France trials in France

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