A Single-center, Prospective Cohort Study on the Differentiation of Benign and Malignant Bile Duct Stenosis Based on Bile and Peripheral Blood cfDNA Methylation Profiles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
The goal of this observational study is to detect the methylation characteristics of cfDNA in the bile and plasma of patients with bile duct stricture. The main question it aims to answer is: Can the developed model, using peripheral blood and bile cell-free DNA sequencing, work well in screening and classifying unknown biliary stricture? Participants will collect approximately 10ml of peripheral blood and 5ml of bile from the patient.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with biliary stricture aged between 18 and 90 years old.
- •Patients scheduled to undergo ERCP surgery due to obstructive jaundice or cholangitis.
- •Definite benign or malignant diagnosis: with a pathological diagnosis of benign or malignant disease, or with follow-up data indicating a benign or malignant diagnosis.
排除标准
- •Receive radiotherapy, chemotherapy, or targeted therapy before sampling.
- •Malignant tumors in other parts of the body (not related to biliary stricture).
- •Unable to determine the nature of the biliary stricture.
- •Ineligible for ERCP due to systemic conditions or gastrointestinal obstruction.
- •Pregnant or breastfeeding women.
- •Unable to sign the informed consent form.
结局指标
主要结局
Diagnostic accuracy
时间窗: Immediately after test completion
This refers to the ability of the test (cell-free DNA sequencing) to correctly classify individuals into the categories of having or not having the disease. It is a measure of the test's overall effectiveness. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Specificity
时间窗: Immediately after test completion
This is the ability of the test (cell-free DNA sequencing) to correctly identify those without disease. It is the proportion of true negative results (those without the disease who test negative) to the total number of individuals who actually do not have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Sensitivity
时间窗: Immediately after test completion
This is the ability of the test (cell-free DNA sequencing) to correctly identify those with the disease. It is the proportion of true positive results (those with the disease who test positive) to the total number of individuals who actually have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.
次要结局
未报告次要终点
研究者
Yanglin Pan
Professor
Air Force Military Medical University, China