Feasibility of Molecular Biology in Pancreatic Cyst Tumors

Not Applicable

Active, not recruiting

• Conditions: Mucinous Cystadenoma; Pancreas Cyst; Serous Cystadenoma; Pancreatic Cyst; IPMN
• Interventions: Genetic: Molecular biology analysis of pancreatic intra-cyst fluid

• Registration Number: NCT03305146
• Lead Sponsor: Hospital St. Joseph, Marseille, France

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-09
• Primary Completion: 2017-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Molecular biology analysis of pancreatic intra-cyst fluid	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Centre Hospitalier Universitaire Dupuytren; 🇫🇷 Limoges, France

Clinique de Bercy; 🇫🇷 Charenton-le-Pont, France

Hopital Mermoz; 🇫🇷 Lyon, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

Hopital Europeen; 🇫🇷 Marseille, France

Hopital Saint Joseph; 🇫🇷 Paris, France

Chu La Timone; 🇫🇷 Marseille, France

CHU NANTES Institut des Maladies de l'Appareil Digestif; 🇫🇷 Nantes, France

Chu L'Archet 2; 🇫🇷 Nice, France

Centre Hospitalier Jacques Lacarin; 🇫🇷 Vichy, France