Actively Recruiting
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE): a Prospective Cohort Study
Led by Peking University Third Hospital · Updated on 2025-05-28
99
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
B
Beijing Tsinghua Changgeng Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Biliary strictures in adults are often caused by serious cancers like pancreatic cancer, bile duct cancer, and metastatic tumors, which have a poor prognosis with unresectable cases typically surviving less than 15 months. Early diagnosis is challenging and crucial because most patients are diagnosed at an advanced stage. Current diagnostic methods like brush cytology and biopsy during ERCP have low sensitivity, and combining these with biomarkers like CA19-9 still does not reach 80% sensitivity. Researchers are exploring the diagnostic value of specific circular DNA molecules (eccDNA) that showed promising accuracy in a small previous study but require further prospective evaluation. This research is a prospective observational study assessing the diagnostic capacity of eccDNA as biomarkers for unclear biliary strictures. Patients suspected of having indeterminate biliary strictures who need ERCP will be observed. The study aims to build on earlier findings where eccDNA showed high sensitivity and specificity in distinguishing malignant biliary conditions. No experimental treatments are given as this is a diagnostic evaluation. Participants will undergo ERCP and related evaluations to collect data on eccDNA markers. The main outcome is whether patients are diagnosed with malignant biliary disease within one year. The study will monitor patients’ diagnostic results and follow them for up to a year to assess the accuracy of eccDNA markers. The study is led by Peking University Third Hospital and enrolls adults aged 18 to 85 years with suspected biliary strictures.
CONDITIONS
Brief Title
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with suspected indeterminate biliary strictures
- Patients who have an indication for undergoing ERCP
You will not qualify if you...
- ERCP failed or unable to obtain bile
- Severe comorbidities
- Predicted overall survival less than 1 year due to other diseases
- Patients unlikely to comply with the protocol or unable to return for follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo diagnostic procedures including ERCP to assess biliary strictures.
1 visit (in-person)
Duration - Up to 1 year
Participants are observed over time to monitor diagnosis outcomes related to biliary disease.
Periodic visits for up to 1 year
Trial Site Locations
Total: 2 locations
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 1000191
Actively Recruiting
2
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
Research Team
Y
Yonghui Huang, M.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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