Evaluating eccDNAs as biomarkers for diagnosing biliary stricture
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE): a Prospective Cohort Study
Peking University Third Hospital · NCT06277531
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 |
|---|---|
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital (other) |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06277531 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients suspected of having indeterminate biliary strictures who are indicated for ERCP.
Not a fit: Patients who have experienced failed ERCP or have severe comorbidities may not benefit from this study.
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 performed: While the approach of using eccDNA as biomarkers is relatively novel, previous studies have indicated potential for success in similar diagnostic applications.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality and 1 other locations
- 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
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.
Conditions: Biliary Stricture, Bile Duct Cancer, Pancreas Cancer, Malignant Biliary Stricture, Cell-Free Extrachromosomal Circular DNA, Liquid-Biopsies Assay