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

Air Force Military Medical University, China161 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

161

Conditions

Bile Duct Neoplasms Jaundice, Obstructive Bile Duct Diseases

Interventions

cfDNA methylation detectionDIAGNOSTIC_TEST

Extract cfDNA from bile and plasma, and perform methylation detection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Patients with biliary stricture aged between 18 and 90 years old. * 2\. Patients scheduled to undergo ERCP surgery due to obstructive jaundice or cholangitis. * 3\. 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. Exclusion Criteria: * 1\. Receive radiotherapy, chemotherapy, or targeted therapy before sampling. * 2\. Malignant tumors in other parts of the body (not related to biliary stricture). * 3\. Unable to determine the nature of the biliary stricture. * 4\. Ineligible for ERCP due to systemic conditions or gastrointestinal obstruction. * 5\. Pregnant or breastfeeding women. * 6\. Unable to sign the informed consent form.

Outcomes

Primary Outcomes

Diagnostic accuracy

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.

Time frame: Immediately after test completion

Sensitivity

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.

Time frame: Immediately after test completion

Specificity

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.

Time frame: Immediately after test completion

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts