Validation of the Proteomic Profiling as a Diagnostic Test for Extra-hepatic Cholangiocarcinoma

NCT06780553 | Not Yet Recruiting

• 1 other identifier: CHUBX 2024/32
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to valide a proof of a concept of the proteomic profiling as a diagnostic tool for bile duct stenosis suspicious of cholangiocarcinoma. The main objective is to evaluate the addition of proteomic profiling to the conventional histological diagnosis of endo-biliary cytological sampling of biliary stenosis, compared with cytological sampling alone. With the addition of proteomic profiling to the conventional histological diagnostic technique, an overall diagnostic sensitivity of 80% is expected

Conditions

Cholangiocarcinoma

Keywords

cholangiocarcinoma; biopsy; diagnosis; proteomic profiling; proteomic

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the proteomic profiling

  Sensitivity of the proteomic profiling test combined with conventional histological diagnosis, compared with the sensitivity of the conventional histological diagnostic test alone.

  Baseline

Secondary Outcomes (2)

• Accuracy of the proteomic profiling

  Baseline

• Molecular pathway of cholangiocarcinogenesis

  Baseline

Study Arms (1)

Suspected cholangiocarcinoma

Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma

Diagnostic Test: Proteomic profiling

Interventions

Proteomic profiling DIAGNOSTIC_TEST

Proteomic profiling as a diagnostic tool in the face of suspected extrahepatic cholangiocarcinoma stenosis

Suspected cholangiocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma

You may qualify if:

• Age ≥ 18 years
• Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma, fixed in formalin and included in paraffin with at least 1 year of follow-up.
• No objection to re-use of data

You may not qualify if:

• Absence of cellular material usable in proteomics on residual histological block
• Presence of pancreatic adenocarcinoma demonstrated on cytological sampling, definitive histology after surgical resection and/or clinical-morphological follow-up of at least one year.
• Patient under legal protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator
• Plateforme Oncoprot (TBMCore 3427 - US005, Bordeaux Biologie Santé): collaborator

Study Sites (1)

CHU Bordeaux

Pessac, France

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Disease

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)