Clinical trial NCT06115655: 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
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bile Duct Neoplasms
Jaundice, Obstructive
Bile Duct Diseases
Keywords: Methylation
Liquid Biopsy
Cell-Free Nucleic Acids
Cancer Diagnosis
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: Immediately after test completion
measure: Sensitivity
timeFrame: Immediately after test completion
measure: Specificity
timeFrame: Immediately after test completion
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of the Air Force Medical University
state: Shaanxi
Study officials:
affiliation: The First Affiliated Hospital of the Air Force Medical University
name: Yanglin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorrell R, Pawa S, Zhou Y, Lalwani N, Pawa R. The Diagnostic Dilemma of Malignant Biliary Strictures. Diagnostics (Basel). 2020 May 25;10(5):337. doi: 10.3390/diagnostics10050337.
citation: Dumonceau JM, Delhaye M, Charette N, Farina A. Challenging biliary strictures: pathophysiological features, differential diagnosis, diagnostic algorithms, and new clinically relevant biomarkers - part 1. Therap Adv Gastroenterol. 2020 Jun 16;13:1756284820927292. doi: 10.1177/1756284820927292. eCollection 2020.
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