Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)

Pancreas Cancer Clinical Trial

— ECCBILE  

Official title:

Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE): a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277531
• Other study ID #: IRB00006761-M2024086
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: January 2024
• Source: Peking University Third Hospital
• Contact: Yonghui Huang, M.D
• Phone: +86-13911765322
• Email: 13911765322[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2026
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients is suspected indetermined biliary strictures

• Patients have the indication for brush cytology during ERCP

Exclusion Criteria:

• ERCP or brush cytology 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

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Biliary Stricture
• Cholangiocarcinoma
• Cholestasis
• Constriction, Pathologic
• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Tsinghua Changgeng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient is diagnosed with malignant disease from biliary system	Malignant tumor is confirmed by histopathology or cytopathology. If the pathology remains unclear, 2 gastroenterologists will finally confirm the diagnosis of the bile duct stricture after 1 year follow-up.	in one year