Feasibility of Molecular Biology in Pancreatic Cyst Tumors

NCT03305146 | Active Not Recruiting

• 1 other identifier: 2016-A01399-42
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 11

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.

Conditions

Pancreatic Cyst; Pancreas Cyst; Serous Cystadenoma; Mucinous Cystadenoma; IPMN

Outcome Measures

Primary Outcomes (1)

• Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen

  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

  10 days

Secondary Outcomes (1)

• Evaluate the feasibility of the molecular biology analysis of the pancreatic cystic tumor fluid to distinguish the pancreatic cysts.

  up to 6 months

Study Arms (1)

single arm

EXPERIMENTAL

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.

Genetic: Molecular biology analysis of pancreatic intra-cyst fluid

Interventions

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.

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead
• Ramsay Générale de Santé: collaborator

Study Sites (11)

Clinique de Bercy

Charenton-le-Pont, 94220, France

Location

Centre Hospitalier Universitaire Dupuytren

Limoges, 87000, France

Location

Hopital Edouard Herriot

Lyon, 69003, France

Location

Hopital Mermoz

Lyon, 69008, France

Location

Hopital Europeen

Marseille, 13003, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Chu La Timone

Marseille, 13385, France

Location

CHU NANTES Institut des Maladies de l'Appareil Digestif

Nantes, 44000, France

Location

Chu L'Archet 2

Nice, 06200, France

Location

Hopital Saint Joseph

Paris, 75014, France

Location

Centre Hospitalier Jacques Lacarin

Vichy, 03207, France

Location

Related Publications (23)

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MeSH Terms

Conditions

Pancreatic Cyst; Cystadenoma, Serous; Cystadenoma, Mucinous

Condition Hierarchy (Ancestors)

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

Study Officials

• Arthur Laquière, MD

  French Society of Digestive Endoscopy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr Arthur LAQUIERE

Model Details: First 20 patients for pilot study to test the feasibility of the molecular analysis then 120 patients to continue the trial.

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: October 9, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)