Clinical trial NCT03305146: Feasibility of Molecular Biology in Pancreatic Cyst Tumors
Official title: Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cyst
Pancreas Cyst
Serous Cystadenoma
Mucinous Cystadenoma
IPMN
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
Collaborators: name: Ramsay Générale de Santé
First posted: 2017-10-09
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First 20 patients for pilot study to test the feasibility of the molecular analysis then 120 patients to continue the trial.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen
timeFrame: 10 days
Secondary outcomes:
measure: Evaluate the feasibility of the molecular biology analysis of the pancreatic cystic tumor fluid to distinguish the pancreatic cysts.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Charenton-le-Pont
country: France
facility: Clinique de Bercy
city: Limoges
country: France
facility: Centre Hospitalier Universitaire Dupuytren
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Lyon
country: France
facility: Hopital Mermoz
city: Marseille
country: France
facility: Hopital Europeen
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Marseille
country: France
facility: Chu La Timone
city: Nantes
country: France
facility: CHU NANTES Institut des Maladies de l'Appareil Digestif
city: Nice
country: France
facility: Chu L'Archet 2
city: Paris
country: France
facility: Hopital Saint Joseph
city: Vichy
country: France
facility: Centre Hospitalier Jacques Lacarin
Study officials:
affiliation: French Society of Digestive Endoscopy
name: Arthur Laquière, MD
role: PRINCIPAL_INVESTIGATOR
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