Clinical trial · Observational
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
NCT06115655CI-TRIAL-00071066unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Diseases | — | UNRESOLVED | — |
| Bile Duct Neoplasms | Bile Duct Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Jaundice, Obstructive | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cfDNA methylation detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- malignant patients
- description
- The presence of biliary stricture due to malignant diseases, such as cholangiocarcinoma.
- interventionNames
- Diagnostic Test: cfDNA methylation detection
- label
- benign patients
- description
- The presence of biliary stricture due to benign diseases, such as inflammation.
- interventionNames
- Diagnostic Test: cfDNA methylation detection
Primary outcomes (3)
- measure
- Diagnostic accuracy
- timeFrame
- Immediately after test completion
- description
- This refers to the ability of the test (cell-free DNA sequencing) to correctly classify individuals into the categories of having or not having the disease. It is a measure of the test's overall effectiveness. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDDorrell 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. PMID 32466095
- BACKGROUNDDumonceau JM, Delhaye M, Charette N, Farina A. Challenging biliary strictures: pathophysiological features, differential diagnosis, diagnostic algorithms, and new clinically relevant biomarkers - part 1. Ther Adv Gastroenterol. 2020 Jun 16;13:1756284820927292. doi: 10.1177/1756284820927292. eCollection 2020. PMID 32595761
- BACKGROUNDSun B, Moon JH, Cai Q, Rerknimitr R, Ma S, Lakhtakia S, Ryozawa S, Kutsumi H, Yasuda I, Shiomi H, Li X, Li W, Zhang X, Itoi T, Wang HP, Qian D, Wong Lau JY, Yang Z, Ji M, Hu B; Asia-Pacific ERCP Club. Review article: Asia-Pacific consensus recommendations on endoscopic tissue acquisition for biliary strictures. Aliment Pharmacol Ther. 2018 Jul;48(2):138-151. doi: 10.1111/apt.14811. Epub 2018 Jun 7. PMID 29876948
- BACKGROUNDDavalos V, Esteller M. Cancer epigenetics in clinical practice. CA Cancer J Clin. 2023 Jul-Aug;73(4):376-424. doi: 10.3322/caac.21765. Epub 2022 Dec 13. PMID 36512337
- BACKGROUNDVedeld HM, Grimsrud MM, Andresen K, Pharo HD, von Seth E, Karlsen TH, Honne H, Paulsen V, Farkkila MA, Bergquist A, Jeanmougin M, Aabakken L, Boberg KM, Folseraas T, Lind GE. Early and accurate detection of cholangiocarcinoma in patients with primary sclerosing cholangitis by methylation markers in bile. Hepatology. 2022 Jan;75(1):59-73. doi: 10.1002/hep.32125. Epub 2021 Dec 5. PMID 34435693
- BACKGROUNDGoeppert B, Stichel D, Toth R, Fritzsche S, Loeffler MA, Schlitter AM, Neumann O, Assenov Y, Vogel MN, Mehrabi A, Hoffmann K, Kohler B, Springfeld C, Weichenhan D, Plass C, Esposito I, Schirmacher P, von Deimling A, Roessler S. Integrative analysis reveals early and distinct genetic and epigenetic changes in intraductal papillary and tubulopapillary cholangiocarcinogenesis. Gut. 2022 Feb;71(2):391-401. doi: 10.1136/gutjnl-2020-322983. Epub 2021 Jan 19.