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

NCT06277531 | Recruiting DMC

• 1 other identifier: IRB00006761-M2024086
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

Biliary Stricture; Bile Duct Cancer; Pancreas Cancer

Keywords

Malignant Biliary Stricture; Cell-Free Extrachromosomal Circular DNA (eccDNA); Liquid-Biopsies Assay

Outcome Measures

Primary Outcomes (1)

• Patient is diagnosed with malignant disease from biliary system

  Malignant tumor is confirmed by histopathology or cytopathology. If the pathology is unclear or inaccessible, 2 gastroenterologists will finally confirm the diagnosis of the bile duct stricture after 1 year follow-up.

  in one year

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are suspected indetermined biliary strictures

You may qualify if:

• Patients is suspected indetermined biliary strictures
• Patients have the indication for ERCP

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Tsinghua Changgeng Hospital: collaborator

Study Sites (2)

Peking University Third Hospital

Beijing, Beijing Municipality, 1000191, China

RECRUITING

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

ERCP-obtained bile specimens were centrifuged at 4600 × g for 10 minutes at 4 °C and the supernatants were stored at -80 °C CfDNA was extracted from 0.5 mL of bile specimens and linear DNA was completely digested. For sequencing, after rolling circle amplification, the Nanopore sequencing library for eccDNA was prepared using the ligation sequencing kit and sequenced on a PromethION platform according to the manufacturer's instructions.

MeSH Terms

Conditions

Bile Duct Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Yonghui Huang

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghui Huang, M.D

CONTACT

+86-13911765322; 13911765322@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)