Feasibility of Molecular Biology in Pancreatic Cyst Tumors
NCT ID: NCT03305146
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
93 participants
INTERVENTIONAL
2017-01-31
2027-01-31
Brief Summary
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The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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single arm
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Cystic tumor of the pancreas requiring a puncture under endoscopic control to determine the etiologic diagnosis and gravity.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ramsay Générale de Santé
OTHER
Hospital St. Joseph, Marseille, France
OTHER
Responsible Party
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Arthur Laquiere
Principal Investigator Dr Arthur LAQUIERE
Principal Investigators
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Arthur Laquière, MD
Role: PRINCIPAL_INVESTIGATOR
French Society of Digestive Endoscopy
Locations
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Clinique de Bercy
Charenton-le-Pont, , France
Centre Hospitalier Universitaire Dupuytren
Limoges, , France
Hopital Edouard Herriot
Lyon, , France
Hopital Mermoz
Lyon, , France
Hopital Europeen
Marseille, , France
Hopital Saint Joseph
Marseille, , France
Chu La Timone
Marseille, , France
CHU NANTES Institut des Maladies de l'Appareil Digestif
Nantes, , France
Chu L'Archet 2
Nice, , France
Hopital Saint Joseph
Paris, , France
Centre Hospitalier Jacques Lacarin
Vichy, , France
Countries
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References
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Other Identifiers
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2016-A01399-42
Identifier Type: -
Identifier Source: org_study_id
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