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Active, Not Recruiting

NCT Number: NCT03305146

Feasibility of Molecular Biology in Pancreatic Cyst Tumors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Cyst Adenoma Cystadenoma Cystadenoma, Mucinous Cystadenoma, Serous Cysts Digestive System Diseases IPMN Mucinous Cystadenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Glandular and Epithelial Pancreas Cyst Pancreatic Diseases Serous Cystadenoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de Bercy, Charenton-le-Pont, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molecular biology analysis of pancreatic intra-cyst fluid

Genetic

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Registry information

Official study title

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

Acronym: CYST-GEN

Important dates

Study start
2017
Primary completion
2017
Study completion
2027
First posted
Oct 9, 2017
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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