跳至主要内容
临床试验/NCT06232538
NCT06232538进行中(未招募)不适用

A Prospective, Multi-centre, Single-blinded Study of UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1
试验地点
1
主要终点
UCAD can be used as a diagnostic technology for gallbladder cancer with the sensitivity more than 90%

研究概览

简要总结

Copy number variation(CNV) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CNV is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CNV of the DNA extracted from bile samples in gallbladder seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with gallbladder cancer. CNV can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. The investigators here intend to study whether a new method named Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CNV thus helping diagnose gallbladder cancer and assessing follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients diagnosed with gallbladder disease and planned to undergo surgery.
  • Male or female patients aged >= 18 years.
  • Participants signed informed consent form.

排除标准

  • Participants had other tumor expect gallbladder cancer

结局指标

主要结局

UCAD can be used as a diagnostic technology for gallbladder cancer with the sensitivity more than 90%

时间窗: 2025

Ultrasensitive chromosomal aneuploidy detection (UCAD) uses low-coverage whole-genome sequencing technology to detect DNA chromosomal instability in samples. By detecting DNA extracted from patients' bile and blood, bioinformatics can be used to analyze the differences in CNV between benign and malignant gallbladder diseases, and a prediction model for gallbladder cancer.

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 (1)

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