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2024-01-01
2026-12-31
2026-12-31
260
NCT07007832
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OBSERVATIONAL
Bile Omics for Diagnosing Indeterminate Biliary Strictures
The diagnosis of malignant biliary strictures remains a challenging aspect of biliary endoscopy. Molecular biological testing techniques based on bile have been reported to improve detection rates. However, whether the combination of bile-based omics studies and biliary brush cytology/biopsy can enhance diagnostic sensitivity has not yet been reported. This study aims to collect bile from patients with malignant biliary strictures, screen for molecular markers associated with biliary malignancies through multi-omics analysis, and subsequently validate these markers to establish a bile-based molecular diagnostic model.
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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 |
|---|---|---|
2025-05-29 | N/A | 2025-06-07 |
2025-06-05 | N/A | 2025-06-11 |
2025-06-06 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
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Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : indeterminate biliary strictures Pathologically or clinical confirmed | PROCEDURE: Endoscopic retrograde cholangiopancreatography
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diagnostic sensitivity | histologically or cytogically confirmed , or followed up for 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| accuracy | histologically or cytologically confirmed or followed up for 6 months | |
| Specificity | histologically or cytologically confirmed or followed up for 6 months | |
| Positive predictive value, | histologically or cytologically confirmed or followed up for 6 months | |
| negative predictive value | histologically or cytologically confirmed or followed up for 6 months | |
| AUC area (histologically or cytologically confirmed or followed up for 6 months) | up for 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xiaobo Cai, MD Phone Number: 86+13918177123 Email: caixiaobo1979@hotmail.com |
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:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
