Identifying benign and malignant bile duct conditions using DNA analysis
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
This study is testing if analyzing DNA from blood and bile can help doctors tell the difference between non-cancerous and cancerous bile duct conditions in patients needing surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 161 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06115655 on ClinicalTrials.gov |
What this trial studies
This observational study aims to differentiate between benign and malignant bile duct stenosis by analyzing the methylation profiles of cell-free DNA (cfDNA) obtained from bile and peripheral blood. Participants will provide samples of approximately 10ml of blood and 5ml of bile, which will be sequenced to develop a model for screening and classifying unknown biliary strictures. The study focuses on patients scheduled for ERCP surgery due to obstructive jaundice or cholangitis, and it seeks to improve diagnostic accuracy in this area.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 90 with biliary stricture who are scheduled for ERCP surgery.
Not a fit: Patients with other malignant tumors, those who have received prior cancer treatments, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing bile duct conditions, leading to better treatment decisions for patients.
How similar studies have performed: While the approach of using cfDNA methylation profiles is gaining traction, this specific application in bile duct stenosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an, Shaanxi
- The First Affiliated Hospital of the Air Force Medical University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Yanglin Pan, MD — The First Affiliated Hospital of the Air Force Medical University
- Study coordinator: Yanglin Pan, MD
- Email: panyl@fmmu.edu.cn
- Phone: +86-13991811225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.