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NCT07007832Recruiting

Bile Omics for Diagnosing Indeterminate Biliary Strictures

The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures

Source: ClinicalTrials.gov · Last updated 11 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
260 (estimated)
First submitted
29 May 2025
Start date
1 Jan 2024
Primary completion date
31 Dec 2026
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NCT number
NCT07007832

What you commit to

  • Study type: Observational
  • Planned participants: 260
  • From 1 Jan 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Coagulation disorders
  • Malignancies of other organs unrelated to biliary strictures

Other

  • Pregnancy
  • Declined participation

Who the study is looking for

  • Indeterminate biliary strictures
  • Aged 18-90 years
  • Underwent ERCP with biliary biopsy and/or brush cytology

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.