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Feasibility of Molecular Biology in Pancreatic Cyst Tumors (CYST-GEN)

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ClinicalTrials.gov Identifier: NCT03305146
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Ramsay Générale de Santé
Information provided by (Responsible Party):
Arthur Laquiere, 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cyst Pancreas Cyst Serous Cystadenoma Mucinous Cystadenoma IPMN Genetic: Molecular biology analysis of pancreatic intra-cyst fluid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Intervention Model Description: First 20 patients for pilot study to test the feasibility of the molecular analysis then 120 patients to continue the trial.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: 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.

Genetic: 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.





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305146


Contacts
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Contact: Laurence Lecomte 33491808207 llecomte@hopital-saint-joseph.fr

Locations
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France
Clinique de Bercy Not yet recruiting
Charenton-le-Pont, France, 94220
Contact: DAVID KARSENTI, MD         
Centre Hospitalier Universitaire Dupuytren Not yet recruiting
Limoges, France, 87000
Contact: JEREMIE JACQUES, MD         
Sub-Investigator: ROMAIN LEGROS, MD         
Sub-Investigator: HUGO PETIT, MD         
Hopital Edouard Herriot Not yet recruiting
Lyon, France, 69003
Contact: MATHIEU PIOCHE, MD         
Sub-Investigator: FLORIAN ROSTAIN, MD         
Sub-Investigator: JEROME RIVORY, MD         
Hopital Mermoz Recruiting
Lyon, France, 69008
Contact: BERTRAND NAPOLEON, MD    33478082354    dr.napoleon@wanadoo.fr   
Sub-Investigator: BERTRAND FUMEX, MD         
Sub-Investigator: RODICA GINCUL, MD         
Sub-Investigator: CHRISTINE LEFORT, MD         
Hopital Europeen Recruiting
Marseille, France, 13003
Contact: VINCENT VALANTIN, MD    33491907770    v.valantin@hopital-europeen.fr   
Sub-Investigator: CLIO LOEVE, MD         
Sub-Investigator: XAVIER LAGRANGE, MD         
Sub-Investigator: THIERRY HELBERT, MD         
Hopital Saint Joseph Recruiting
Marseille, France, 13008
Contact: ARTHUR LAQUIERE, MD    33491808207    alaquiere@gmail.com   
Contact: LAURENCE LECOMTE    33491808207    llecomte@hopital-saint-joseph.fr   
Chu La Timone Recruiting
Marseille, France, 13385
Contact: PHILIPPE GRANDVAL, MD    33491388213    philippe.grandval@ap-hm.fr   
Sub-Investigator: LAURENT HEYRIES, MD         
Sub-Investigator: MARINE BARRAUD, MD         
CHU NANTES Institut des Maladies de l'Appareil Digestif Not yet recruiting
Nantes, France, 44000
Contact: EMMANUEL CORON, MD         
Chu L'Archet 2 Not yet recruiting
Nice, France, 06200
Contact: GEOFFROY VANBIERVLIETMD         
Hopital Saint Joseph Not yet recruiting
Paris, France, 75014
Contact: YANN LE BALEUR, MD         
Centre Hospitalier Jacques Lacarin Not yet recruiting
Vichy, France, 03207
Contact: JOCELYN PRIVAT, MD         
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
Ramsay Générale de Santé
Investigators
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Principal Investigator: Arthur Laquière, MD French Society of Digestive Endoscopy

Publications:
Springer S, Wang Y, Dal Molin M, Masica DL, Jiao Y, Kinde I, Blackford A, Raman SP, Wolfgang CL, Tomita T, Niknafs N, Douville C, Ptak J, Dobbyn L, Allen PJ, Klimstra DS, Schattner MA, Schmidt CM, Yip-Schneider M, Cummings OW, Brand RE, Zeh HJ, Singhi AD, Scarpa A, Salvia R, Malleo G, Zamboni G, Falconi M, Jang JY, Kim SW, Kwon W, Hong SM, Song KB, Kim SC, Swan N, Murphy J, Geoghegan J, Brugge W, Fernandez-Del Castillo C, Mino-Kenudson M, Schulick R, Edil BH, Adsay V, Paulino J, van Hooft J, Yachida S, Nara S, Hiraoka N, Yamao K, Hijioka S, van der Merwe S, Goggins M, Canto MI, Ahuja N, Hirose K, Makary M, Weiss MJ, Cameron J, Pittman M, Eshleman JR, Diaz LA Jr, Papadopoulos N, Kinzler KW, Karchin R, Hruban RH, Vogelstein B, Lennon AM. A combination of molecular markers and clinical features improve the classification of pancreatic cysts. Gastroenterology. 2015 Nov;149(6):1501-10. doi: 10.1053/j.gastro.2015.07.041. Epub 2015 Aug 4.

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Responsible Party: Arthur Laquiere, Principal Investigator Dr Arthur LAQUIERE, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT03305146     History of Changes
Other Study ID Numbers: 2016-A01399-42
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cystadenoma
Cystadenoma, Mucinous
Cystadenoma, Serous
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous