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

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT06115655

Collaborator

(none)

161

Enrollment

Location

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bile Duct Neoplasms Jaundice, Obstructive Bile Duct Diseases	Diagnostic Test: cfDNA methylation detection

Study Design

Study Type:

Observational

Anticipated Enrollment :

161 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
malignant patients The presence of biliary stricture due to malignant diseases, such as cholangiocarcinoma.	Diagnostic Test: cfDNA methylation detection Extract cfDNA from bile and plasma, and perform methylation detection.
benign patients The presence of biliary stricture due to benign diseases, such as inflammation.	Diagnostic Test: cfDNA methylation detection Extract cfDNA from bile and plasma, and perform methylation detection.

Arm

Intervention/Treatment

malignant patients

The presence of biliary stricture due to malignant diseases, such as cholangiocarcinoma.

Diagnostic Test: cfDNA methylation detection

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

benign patients

The presence of biliary stricture due to benign diseases, such as inflammation.

Diagnostic Test: cfDNA methylation detection

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

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy [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.
Sensitivity [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.
Specificity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. Patients with biliary stricture aged between 18 and 90 years old.
1. Patients scheduled to undergo ERCP surgery due to obstructive jaundice or cholangitis.
1. 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.
1. Malignant tumors in other parts of the body (not related to biliary stricture).
1. Unable to determine the nature of the biliary stricture.
1. Ineligible for ERCP due to systemic conditions or gastrointestinal obstruction.
1. Pregnant or breastfeeding women.
1. Unable to sign the informed consent form.