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

Recruiting

• Conditions: Bile Duct Diseases; Jaundice, Obstructive; Bile Duct Neoplasms
• Interventions: Diagnostic Test: cfDNA methylation detection

• Registration Number: NCT06115655
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 161

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
malignant patients	cfDNA methylation detection	The presence of biliary stricture due to malignant diseases, such as cholangiocarcinoma.
benign patients	cfDNA methylation detection	The presence of biliary stricture due to benign diseases, such as inflammation.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of the Air Force Medical University; 🇨🇳 Xi'an, Shaanxi, China