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

Trial 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

NCT ID: NCT06115655

Condition: Bile Duct Neoplasms
Jaundice, Obstructive
Bile Duct Diseases

Conditions: Official terms:
Bile Duct Neoplasms
Bile Duct Diseases
Jaundice
Jaundice, Obstructive

Conditions: Keywords:
Methylation
Liquid Biopsy
Cell-Free Nucleic Acids
Cancer Diagnosis

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: cfDNA methylation detection
Description: Extract cfDNA from bile and plasma, and perform methylation detection.
Arm group label: benign patients
Arm group label: malignant patients

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The First Affiliated Hospital of the Air Force Medical University

Address:
City: Xi'an
Zip: 710032
Country: China

Status: Recruiting

Contact:
Last name: Yanglin Pan

Phone: +86-13991811225
Email: panyl@fmmu.edu.cn

Start date: October 1, 2023

Completion date: October 30, 2024

Lead sponsor:
Agency: Air Force Military Medical University, China
Agency class: Other

Source: Air Force Military Medical University, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06115655