NCT06277531 Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)
| NCT ID | NCT06277531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Biliary Stricture |
| Study Type | OBSERVATIONAL |
| Enrollment | 99 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 99 participants in total. It began in 2024-03-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures. Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%. In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.
Eligibility 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
Contact & Investigator
Yonghui Huang
PRINCIPAL INVESTIGATOR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT06277531 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Biliary Stricture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06277531 currently recruiting?
Yes, NCT06277531 is actively recruiting participants. Contact the research team at 13911765322@163.com for enrollment information.
Where is the NCT06277531 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06277531 clinical trial?
NCT06277531 is sponsored by Peking University Third Hospital. The principal investigator is Yonghui Huang at Peking University Third Hospital. The trial plans to enroll 99 participants.