跳至主要内容
临床试验/NCT06729944
NCT06729944招募中不适用

Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours

IRCCS Azienda Ospedaliero-Universitaria di Bologna2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Identification of an NGS panel specific to dysplasia and CCA

研究概览

简要总结

The aim of this study is to identify a dysplasia- and CCA-specific NGS panel to increase the diagnostic sensitivity of histological and/or cytological examination of biliary tract stenosis.

详细描述

Patients undergoing biliary tract resection, as part of the normal course of care, at the O.U. General Surgery and Transplantation will be enrolled. Tissue samples will be processed and analysed at the O.U. of Pathological Anatomy.

Clinical, serological and instrumental data from patients, considered necessary for the intended analyses, will be collected for the purposes of the study.

The study will have a total duration of 36 months. It is planned to enrol 50 patients, all belonging to the U.O. Hepatobiliary and Transplant Surgery of the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The size of the population is estimated on the basis of the number of cases/year from the U.O. Hepatobiliary and Transplant Surgery, and is considered sufficient to achieve the primary objective, since it is an exploratory study. Surgical material (resection of biliary tract, possibly hepatectomy or duodenocephalopancreasectomy), which will be sampled according to clinical practice and sent to the O.U. of Pathological Anatomy of the IRCCS AOUBO, where it will be sampled, fixed in formalin, included in paraffin and processed. From paraffin blocks (selected from those obtained from the sampling of surgical pieces according to clinical practice) 2 µm sections will be cut for Next Generation Sequencing investigations.

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

入选标准

  • Availability of enough tissue for histological and NGS analysis (at least 20 ng DNA).
  • Age greater than/equal to 18 years.

排除标准

  • 未提供

结局指标

主要结局

Identification of an NGS panel specific to dysplasia and CCA

时间窗: During enrollment period, up to 30 months

Ratio between the number of cases identified with NGS panel and the number of cases identified with standard of care

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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