UnknownNot Applicable

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

China161 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic accuracy

Timeframe: Immediately after test completion

Sensitivity

Timeframe: Immediately after test completion

Specificity

Timeframe: Immediately after test completion

Trial details

NCT IDNCT06115655

SponsorAir Force Military Medical University, China

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-01

Contact for this trial

Yanglin Pan, MD

+86-13991811225 panyl@fmmu.edu.cn

View on ClinicalTrials.gov More Bile Duct Neoplasms trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.