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 of People's Liberation Army

Status

Enrolling

Conditions

Jaundice, Obstructive

Bile Duct Neoplasms

Bile Duct Diseases

Treatments

Diagnostic Test: cfDNA methylation detection

Study type

Observational

Funder types

Other

Identifiers

NCT06115655

KY20232312

Details and patient eligibility

About

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.

Enrollment

161 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.