Status:
UNKNOWN
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
Lead Sponsor:
Air Force Military Medical University, China
Conditions:
Bile Duct Neoplasms
Jaundice, Obstructive
Eligibility:
All Genders
18-90 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT06115655
Start Date
October 1 2023
End Date
October 30 2024
Last Update
November 3 2023
Active Locations (1)
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1
The First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi, China, 710032