CholangiocarcinomaPROTEOBILENCT06416397
Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy
An observational study of Cholangiocarcinoma, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The main aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Proteomic profile
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with bile duct stenosis who require ERCP or a radiological procedure for diagnostic purposes (histological samples) as part of their management
Who may be able to join
- 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
Who cannot join
- Pregnant woman
- Patient under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Bordeaux
Pessac
Arthur Marichez, MD, +33557656005, arthur.marichez@chu-bordeaux.fr
About this study
The main aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological sampling and/or final histological sampling).
Read the detailed description
Cholangiocarcinoma has a poor 5-year prognosis (less than 5%) and is rarely resectable at diagnosis. Diagnosis is made by histological sampling (biopsy or endo-biliary brushing) during endoscopic retrograde catheterization of the papilla or radiologically during transparietohepatic drainage. Conventional histology techniques have a low sensitivity of around 14-60%, which leads to diagnostic delays, repeated invasive examinations and delays in therapeutic management, sometimes with progression from a resectable to an unresectable stage.
New techniques are emerging to optimize the diagnosis of cholangiocarcinoma, in particular molecular techniques. This is the case with proteomics and proteomic profiling, which consists of obtaining diagnostic information from all the proteins contained in biological samples.
Furthermore, during diagnostic procedures for cholangiocarcinoma, bile samples are taken, initially for bacteriological purposes. Proteomics has been shown to be a tool capable of identifying potential diagnostic biomarkers in bile samples. To date, proteomic profiling has never been tested on bile samples for diagnostic purposes, although its proof of concept has been established.
Obtaining a proteomic profile for the diagnosis of cholangiocarcinoma from bile samples would enable the development of an innovative tool that has not yet been described in this field. It would optimize the management of patients with cholangiocarcinoma, with the possibility of a quicker diagnosis enabling optimal management as soon as the first clinical symptoms appear, while reducing the number of examinations required to obtain a diagnosis.
- Conditions
- Cholangiocarcinoma
- Being tested
- Proteomic profile
- Keywords
- Cholangiocarcinoma, Diagnosis, Cancer, Proteomic profiling
- Medical subject headings
- Cholangiocarcinoma, Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic profileDiagnostic test
Proteomic analysis of bile samples will be performed every 5 bile samples. Bile samples will be taken during endoscopy with retrograde papillary catheterization or radiological procedures in selected patients. In clinical practice, bile samples are taken for bacteriological purposes. An average of 10 mL is taken.
Five mL are required for bacteriological analysis. The remaining millilitres, which are usually discarded, will be kept for storage and to form the bile bank at the Biological Resources Centre before to be analyzed in proteomics.
What is being measured
The primary outcome is the main question the study is designed to answer.
positive diagnosis of cholangiocarcinoma
rate of positive diagnosis of cholangiocarcinoma obtained from bile samples using proteomic profile analysis compared with the rate of positive diagnosis using histological reference tools.
Measured: Baseline
Secondary outcomes (3)
Identification of diagnostic biomarkers for cholangiocarcinoma
pecific analysis of proteomic data to identify a recurrent, malignancy-specific target protein
Measured: Baseline
differential diagnosis rates
differential diagnosis rates obtained by proteomic profiling compared with histological results
Measured: Baseline
positive diagnoses with the Next-Generation Sequencing technique
rate of positive diagnoses with the Next-Generation Sequencing technique
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start8 Apr 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416397
- Sponsor's protocol ID
- CHUBX 2023/69
- Acronym
- PROTEOBILE
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy
- ClinicalTrials.gov ID
- NCT06416397
- Acronym / sponsor ID
- PROTEOBILE / CHUBX 2023/69
- Conditions
- Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, Diagnosis, Cancer, Proteomic profiling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological sampling and/or final histological sampling).
Detailed description
Cholangiocarcinoma has a poor 5-year prognosis (less than 5%) and is rarely resectable at diagnosis. Diagnosis is made by histological sampling (biopsy or endo-biliary brushing) during endoscopic retrograde catheterization of the papilla or radiologically during transparietohepatic drainage. Conventional histology techniques have a low sensitivity of around 14-60%, which leads to diagnostic delays, repeated invasive examinations and delays in therapeutic management, sometimes with progression from a resectable to an unresectable stage.
New techniques are emerging to optimize the diagnosis of cholangiocarcinoma, in particular molecular techniques. This is the case with proteomics and proteomic profiling, which consists of obtaining diagnostic information from all the proteins contained in biological samples.
Furthermore, during diagnostic procedures for cholangiocarcinoma, bile samples are taken, initially for bacteriological purposes. Proteomics has been shown to be a tool capable of identifying potential diagnostic biomarkers in bile samples. To date, proteomic profiling has never been tested on bile samples for diagnostic purposes, although its proof of concept has been established.
Obtaining a proteomic profile for the diagnosis of cholangiocarcinoma from bile samples would enable the development of an innovative tool that has not yet been described in this field. It would optimize the management of patients with cholangiocarcinoma, with the possibility of a quicker diagnosis enabling optimal management as soon as the first clinical symptoms appear, while reducing the number of examinations required to obtain a diagnosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with bile duct stenosis who require ERCP or a radiological procedure for diagnostic purposes (histological samples) as part of their management
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant woman
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteomic profileProteomic analysis of bile samples will be performed every 5 bile samples. Bile samples will be taken during endoscopy with retrograde papillary catheterization or radiological procedures in selected patients. In clinical practice, bile samples are taken for bacteriological purposes. An average of 10 mL is taken. Five mL are required for bacteriological analysis. The remaining millilitres, which are usually discarded, will be kept for storage and to form the bile bank at the Biological Resources Centre before to be analyzed in proteomics. | Diagnostic test | – |
Primary outcome
positive diagnosis of cholangiocarcinoma
Time frame: Baseline
rate of positive diagnosis of cholangiocarcinoma obtained from bile samples using proteomic profile analysis compared with the rate of positive diagnosis using histological reference tools.
3 secondary outcomes
Identification of diagnostic biomarkers for cholangiocarcinoma
Time frame: Baseline
differential diagnosis rates
Time frame: Baseline
positive diagnoses with the Next-Generation Sequencing technique
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur Marichez, MD (+33557656005, arthur.marichez@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive diagnosis of cholangiocarcinoma (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.