Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 93
- 试验地点
- 21
- 主要终点
- Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen
时间窗: 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
次要结局
- Evaluate the feasibility of the molecular biology analysis of the pancreatic cystic tumor fluid to distinguish the pancreatic cysts.(up to 6 months)
研究者
Arthur Laquiere
Principal Investigator Dr Arthur LAQUIERE
Hospital St. Joseph, Marseille, France