An interventional study of Molecular biology analysis of pancreatic intra-cyst fluid in Pancreatic Cyst, Pancreas Cyst and Serous Cystadenoma, sponsored by Hospital St. Joseph, Marseille, France. Active, not recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Hospital St. Joseph, Marseille, France · Not applicable, Interventional, and Diagnostic
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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.
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.
97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.
This study's enrollment of 93 is above the median of 84 across 38 interventional studies indexed under Pancreatic Cyst.
Browse Pancreatic Cyst studies →Hospital St. Joseph, Marseille, France is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: 10 days
Evaluate the feasibility of the molecular biology analysis of the pancreatic cystic tumor fluid to distinguish the pancreatic cysts.
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
Time frame: up to 6 months
Plan to share: No
Ran from Jan 2017 to primary completion in Dec 2017, 11 months.
Of 17 interventional studies with no phase under Pancreatic Cyst, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's 11 months is below that.
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This study is active, not recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Hospital St. Joseph, Marseille, France