Evaluating eccDNAs as biomarkers for diagnosing biliary stricture
Official title: Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE): a Prospective Cohort Study
Run by Peking University Third Hospital · NCT06277531 · Data updated 2026-11-12
This study is testing if a new type of DNA found in the blood can help doctors better diagnose patients with unclear bile duct blockages, especially to catch cancer earlier.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 99 (estimated) |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | July 1, 2025 |
| Study ends | July 1, 2026 |
| Registry record updated | May 28, 2025 |
| Trial ID | NCT06277531 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients suspected of having indeterminate biliary strictures who are indicated for ERCP.
✕Probably not a fit
Patients who have experienced failed ERCP or have severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the diagnostic capacity of cell-free extrachromosomal circular DNA (eccDNA) as biomarkers in patients with indeterminate biliary stricture. The study focuses on improving early diagnosis of malignant biliary strictures, which are often associated with poor prognosis due to late-stage presentation. Current diagnostic methods like brush cytology and biopsy during ERCP have low sensitivity, prompting the need for novel strategies. By analyzing eccDNA, the study seeks to enhance the accuracy of diagnosing conditions such as bile duct cancer and pancreatic cancer.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of malignant biliary strictures, improving patient outcomes.
How similar studies have gone: While the approach of using eccDNA as biomarkers is relatively novel, previous studies have indicated potential for success in similar diagnostic applications.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients is suspected indetermined biliary strictures * Patients have the indication for ERCP Exclusion Criteria: * ERCP failed, or can not obtain bile * Sever comorbidities * Predicted overall survival less than 1 year because of other disease * Patients who are unlikely to comply with the protocol, inability to return for subsequent visits
Where it's running
-
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting -
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Yonghui Huang — Peking University Third Hospital
- Study coordinator: Yonghui Huang, M.D
- Email: 13911765322@163.com
- Phone: +86-13911765322
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.