Evaluation Of DiagnostiC Capacity Of EccDNAs As Biomarkers In Indetermined BiLiary Stricture(ECCBILE)

Study Overview

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

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.

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Biliary Stricture
Bile Duct Cancer
Pancreas Cancer

IRB00006761-M2024086

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-02-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-25
First Submitted that Met QC Criteria 2024-02-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-29
First Posted (ACTUAL) 2024-02-26	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yonghui Huang, M.D

Phone Number: +86-13911765322

Email: 13911765322@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Beijing Tsinghua Changgeng Hospital

Investigators

PRINCIPAL_INVESTIGATOR: Yonghui Huang, Peking University Third Hospital

Publications

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General Publications

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Clinical Trial Record