Validation of the Proteomic Profiling as a Diagnostic Test for Extra-hepatic Cholangiocarcinoma (NCT06780553) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validation of the Proteomic Profiling as a Diagnostic Test for Extra-hepatic Cholangiocarcinoma
France60 participantsStarted 2025-11
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on testing proteomic profiling as a diagnostic tool for extra-hepatic cholangiocarcinoma — does my specific diagnosis match that type, and would this test give us any useful information about my situation?
2Since this trial is listed as 'not yet recruiting,' how long might it realistically be before it opens, and are there other diagnostic or treatment options I should be pursuing in the meantime rather than waiting?
3The trial seems to be about validating a diagnostic test rather than treating the cancer itself — does that mean participating wouldn't change my actual treatment plan, and what would I personally gain by taking part?
4Proteomic profiling looks at proteins in the body to try to detect cancer — can you explain how accurate this approach is expected to be compared to the diagnostic methods I've already had, and what the trial is trying to prove about its sensitivity?
5Are there any other trials or established treatments for extra-hepatic cholangiocarcinoma that I should be considering alongside or instead of this diagnostic study, given that this one is not yet open and isn't offering a therapy?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.