Clinical trial · Interventional
Feasibility of Molecular Biology in Pancreatic Cyst Tumors
Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.
NCT03305146CI-TRIAL-00057832CYST-GENactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| IPMN | — | UNRESOLVED | — |
| Mucinous Cystadenoma | Mucinous Cystadenoma | ONTOLOGY_EXACT | 0.98 |
| Pancreas Cyst | — | UNRESOLVED | — |
| Pancreatic Cyst | — | UNRESOLVED | — |
| Serous Cystadenoma | Serous Cystadenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular biology analysis of pancreatic intra-cyst fluid | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- 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.
- interventionNames
- Genetic: Molecular biology analysis of pancreatic intra-cyst fluid
Primary outcomes (1)
- measure
- Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen
- timeFrame
- 10 days
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (23)
- BACKGROUNDLee KS, Sekhar A, Rofsky NM, Pedrosa I. Prevalence of incidental pancreatic cysts in the adult population on MR imaging. Am J Gastroenterol. 2010 Sep;105(9):2079-84. doi: 10.1038/ajg.2010.122. Epub 2010 Mar 30. PMID 20354507
- BACKGROUNDFarrell JJ, Fernandez-del Castillo C. Pancreatic cystic neoplasms: management and unanswered questions. Gastroenterology. 2013 Jun;144(6):1303-15. doi: 10.1053/j.gastro.2013.01.073. PMID 23622140
- BACKGROUNDTerris B, Ponsot P, Paye F, Hammel P, Sauvanet A, Molas G, Bernades P, Belghiti J, Ruszniewski P, Flejou JF. Intraductal papillary mucinous tumors of the pancreas confined to secondary ducts show less aggressive pathologic features as compared with those involving the main pancreatic duct. Am J Surg Pathol. 2000 Oct;24(10):1372-7. doi: 10.1097/00000478-200010000-00006. PMID 11023098
- BACKGROUNDCrippa S, Fernandez-Del Castillo C, Salvia R, Finkelstein D, Bassi C, Dominguez I, Muzikansky A, Thayer SP, Falconi M, Mino-Kenudson M, Capelli P, Lauwers GY, Partelli S, Pederzoli P, Warshaw AL. Mucin-producing neoplasms of the pancreas: an analysis of distinguishing clinical and epidemiologic characteristics. Clin Gastroenterol Hepatol. 2010 Feb;8(2):213-9. doi: 10.1016/j.cgh.2009.10.001. Epub 2009 Oct 14. PMID 19835989
- BACKGROUNDMarchegiani G, Mino-Kenudson M, Sahora K, Morales-Oyarvide V, Thayer S, Ferrone C, Warshaw AL, Lillemoe KD, Fernandez-Del Castillo C. IPMN involving the main pancreatic duct: biology, epidemiology, and long-term outcomes following resection. Ann Surg. 2015 May;261(5):976-83. doi: 10.1097/SLA.0000000000000813. PMID 24979607
- BACKGROUNDTanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.