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

October 30, 2023 updated by: Yanglin Pan, Air Force Military Medical University, China
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The First Affiliated Hospital of the Air Force Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

According to the "Sample Size Calculation for Comparative Diagnostic Studies with Categorical Variables (Rates)" method, it is calculated. Based on the previous research results, it is estimated that the diagnostic sensitivity of sequencing methylation profiles in bile cfDNA is 82%, the specificity is 95%, the allowable error in sensitivity is 0.1, the allowable error in specificity is 0.1, α is set to 0.05, the loss to follow-up rate is 10%, and the calculated sample size is approximately 161 cases.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: 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.
Immediately after test completion
Sensitivity
Time Frame: 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.
Immediately after test completion
Specificity
Time Frame: 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.
Immediately after test completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Yanglin Pan, MD, The First Affiliated Hospital of the Air Force Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Estimated)

November 3, 2023

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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