Bile proteomic test to diagnose cholangiocarcinoma
Official title: Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy
Run by University Hospital, Bordeaux · NCT06416397 · Data updated 2026-11-12
We will try a proteomic analysis of bile to see if it can detect cholangiocarcinoma in adults who are having diagnostic bile sampling.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac) |
| Status | Recruiting |
| Started | April 8, 2025 |
| Main results expected | February 2026 |
| Study ends | February 2026 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT06416397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with biliary strictures who are scheduled for diagnostic ERCP or radiologic biliary drainage and who can give oral consent are the intended participants.
✕Probably not a fit
Pregnant people, individuals under legal protection, or patients who will not have bile sampling as part of their care are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project aims to create a diagnostic proteomic profile for cholangiocarcinoma using bile collected during routine endoscopic or radiologic biliary procedures. Bile obtained during ERCP or percutaneous biliary drainage will undergo proteomic profiling and the results will be compared with concurrent cytology/biopsy or final histological diagnoses. The primary endpoint is the rate of concordant positive diagnoses between bile proteomics and the histological reference standard. The approach builds on prior proteomic biomarker work in bile and other biofluids to develop a minimally invasive diagnostic tool.
Why it matters
Potential benefit: If successful, this could provide quicker and more accurate diagnosis from bile samples, reducing repeat invasive procedures and allowing earlier treatment decisions.
How similar studies have gone: Proteomic methods have identified potential biomarkers in bile and other fluids, but using proteomic profiling of bile specifically for cholangiocarcinoma diagnosis has not yet been established in clinical practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient 18 years and older * Patients with bile duct stenosis who require endoscopy with retrograde papillary catheterization or a radiological procedure for diagnostic purposes (histological samples) as part of their management * Oral consent Exclusion Criteria: * Pregnant woman * Patient under legal protection
Where it's running
-
CHU Bordeaux
Pessac, France Recruiting
Study contacts
- Study coordinator: Arthur Marichez, MD
- Email: arthur.marichez@chu-bordeaux.fr
- Phone: +33557656005
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SumMET: Targeted radioligand therapy for c-MET–positive solid tumors
This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.
-
68Ga-SorB PET/CT imaging for solid tumors
This study tests a new PET tracer called 68Ga-SorB to see if it can safely and accurately detect tumors in adults with melanoma, liver, lung, breast, pancreatic, ovarian cancer, or cholangiocarcinoma.
-
Breath test to help detect gastrointestinal cancers early
A breath test that looks for signals in exhaled air to see if someone with gut cancer symptoms might have oesophageal, stomach, pancreatic, liver, or colorectal cancer and need urgent testing.
-
Can an imaging tracer help predict if cholangiocarcinoma patients will respond to standard therapy
This study tests whether an imaging tracer called [18F]FTT used with PET/CT can predict how newly diagnosed cholangiocarcinoma patients will respond to the standard treatment of gemcitabine, cisplatin, and durvalumab.
-
Dual-target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
This trial tests a ready-to-use CAR-NK cell therapy that targets HER2 and CEACAM5 in adults with unresectable or metastatic biliary tract cancers after standard therapy to see if it can help control the disease.
-
KRAS G12V cancer patients get TCR1188-ABC cell therapy
This early-phase trial tests whether TCR1188-ABC cells can safely be given to adults with KRAS G12V-mutated metastatic cancers to see if it can help some types of pancreatic, biliary, colorectal, or lung cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.