Biliary Tract Cancer (BTC)REVEAL-BTCNCT07515950
A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER
An observational study of Biliary Tract Cancer (BTC), run by MedSIR.
Trial summary
The REVEAL-BTC Study will analyze 5 biomarkes in samples of participants who in the past 15 year have been diagnosed with any stage of biliary tract cancer. The expression levels of the biomarkers will be correlated with clinical outcomes in the participants, which will lead to better patient stratification that will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2027
- 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
- Adult, Older adult
Study population: Male and female participants with histologically confirmed biliary tract cancer (either GBC or CCA), regardless of disease stage, are eligible. Participants must have been diagnosed within the past 15 years and must have archival tumor tissue available in the form of formalin-fixed-paraffin-embedded (FFPE) samples, collected prior to the start of the Study at any disease stage (e.g., during surgery of the primary or in the advanced setting). Availability of basic clinical and survival data is required for Study participation. Confirmation of consent exemption must be obtained from the ethics committee at the time of submission.
Who may be able to join
- Written informed consent for the use of clinical data and tissue samples is available. (The use of data and samples without consent is only possible if exemption is granted by the corresponding Institutional Review Board - IRB).
- Histologically confirmed diagnosis of biliary tract cancer (including gallbladder carcinoma [GBC] or cholangiocarcinoma [CCA]), regardless of disease stage.
- Diagnosis must have been established within the last 15 years prior to Study initiation.
- Availability of archival formalin-fixed paraffin-embedded (FFPE) tumor tissue sample, collected prior to Study inclusion at any disease stage (e.g., during surgery or in the advanced setting). For patients with de novo metastatic disease or early stage primary tumors undergoing surgery, the tissue must have been obtained before the initiation of any systemic therapy (e.g. chemotherapy) or radiotherapy. For patients with recurrent disease undergoing a new biopsy, previous treatments are allowed.
- Availability and accessibility of basic clinical information and survival data on medical records.
Who cannot join
- Unavailability or inadequate quality (e.g., insufficient tumor content, degraded tissue) of archival FFPE tumor tissue samples for the planned immunohistochemical analysis.
- Missing or incomplete basic clinical and/or survival data in the medical record.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The REVEAL-BTC Study will analyze 5 biomarkes in samples of participants who in the past 15 year have been diagnosed with any stage of biliary tract cancer. The expression levels of the biomarkers will be correlated with clinical outcomes in the participants, which will lead to better patient stratification that will help guide the use of targeted therapies in the future.
Read the detailed description
In the REVEAL.BCT Study, archival tumor tissue samples available from multiple national sites in Spain will be collected alongside basic clinical and survival data of 244 participants. Then, samples will be evaluated for the expression of selected biomarkers (CLDN18.2, TROP2, B7-H4, HER2, and PD-L1) via immunohistochemistry. The main purpose of this analysis is to evaluate the expression levels of the biomarkers and understand its link to the participants' clinical outcome, with the aim to identify specific patient populations and strategies to help clinicians guide the use of targeted therapies in patients according to their markers in the future.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- No intervention
- Keywords
- Biliary tract cancer, CLDN18.2, TROP2, B7-H4, HER-2, PD-L1
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Non applicable
| Study group | Role | What they receive |
|---|---|---|
| Biliary tract cancer (either GBC or CCA) | Participants must have been diagnosed within the past 15 years and must have archival tumor tissue available in the form of formalin-fixedparaffin-embedded (FFPE) samples, collected prior to the start of the Study at any disease stage (e.g., during surgery of the primary or in the advanced setting). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker expression level
To evaluate the expression levels of the following biomarkers that represent potential therapeutic targets -claudin 18.2 (CLDN18.2), human epidermal growth factor receptor 2 (HER2), trophoblast cell surface antigen 2 (TROP2), programmed death-ligand 1 (PD-L1), and B7 homolog 4 (B7-H4)-in a retrospective cohort of participants with biliary tract cancer (BTC), based on immunohistochemistry (IHC) analysis.
Measured: Up to 16 months
Overall biomarker positivity rate
To determine the overall rate of biomarker positivity for each target within the Study population, based on IHC analysis and according to predefined, validated IHC cut-off values.
Measured: Up to 16 months
Percentage of positivity
To assess the percentage of positive tumor cells and tumor associated stromal cells expressing each biomarker, according to predefined, validated IHC cutoff values
Measured: Up to 16 months
Secondary outcomes (4)
Clinical outcome and biomarker expression correlation
To explore the correlation between individual biomarker expression and clinical outcomes, including but not limited to overall survival (OS), in participants with BTC.
Measured: Up to 16 months
Biomarker expression and disease stage correlation
To investigate the relationship between biomarker expression and disease stage at the time of diagnosis.
Measured: Up to 16 months
Co-expression pattern correlation with clinical outcome
To evaluate the association between co-expression patterns of the studied biomarkers and clinical outcomes.
Measured: Up to 16 months
CLDN18.2 analytical validation
To perform analytical validation of the VENTANA CLDN18 (clone 43-14A) IHC assay for the detection of CLDN18.2 isoform expression in formalin-fixed paraffin-embedded (FFPE) tumor samples.
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515950
- Sponsor's protocol ID
- MedOPT0046
- Acronym
- REVEAL-BTC
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected within this study will be made available to researchers after contacting the corresponding author and upon revision and approval based on scientific merit by the trial management group (which includes a qualified statistician) of a detailed proposal for their use. The data required for the approved, specified purposes and the trial protocol will be provided after the completion of a data-sharing agreement that will be set up by the study sponsor. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. Data Sharing should begin 1 month after publication of study main results and ending 5 years after article publication. Estimate timeframe for response will be within 30 days.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER
- ClinicalTrials.gov ID
- NCT07515950
- Acronym / sponsor ID
- REVEAL-BTC / MedOPT0046
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- Biliary tract cancer, CLDN18.2, TROP2, B7-H4, HER-2, PD-L1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 Apr 2026 (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 REVEAL-BTC Study will analyze 5 biomarkes in samples of participants who in the past 15 year have been diagnosed with any stage of biliary tract cancer. The expression levels of the biomarkers will be correlated with clinical outcomes in the participants, which will lead to better patient stratification that will help guide the use of targeted therapies in the future.
Detailed description
In the REVEAL.BCT Study, archival tumor tissue samples available from multiple national sites in Spain will be collected alongside basic clinical and survival data of 244 participants. Then, samples will be evaluated for the expression of selected biomarkers (CLDN18.2, TROP2, B7-H4, HER2, and PD-L1) via immunohistochemistry. The main purpose of this analysis is to evaluate the expression levels of the biomarkers and understand its link to the participants' clinical outcome, with the aim to identify specific patient populations and strategies to help clinicians guide the use of targeted therapies in patients according to their markers in the future.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biliary tract cancer (either GBC or CCA) | – | Other: No interventionParticipants must have been diagnosed within the past 15 years and must have archival tumor tissue available in the form of formalin-fixedparaffin-embedded (FFPE) samples, collected prior to the start of the Study at any disease stage (e.g., during surgery of the primary or in the advanced setting). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and female participants with histologically confirmed biliary tract cancer (either GBC or CCA), regardless of disease stage, are eligible. Participants must have been diagnosed within the past 15 years and must have archival tumor tissue available in the form of formalin-fixed-paraffin-embedded (FFPE) samples, collected prior to the start of the Study at any disease stage (e.g., during surgery of the primary or in the advanced setting). Availability of basic clinical and survival data is required for Study participation. Confirmation of consent exemption must be obtained from the ethics committee at the time of submission.
Key inclusion criteria (5 listed)
- Written informed consent for the use of clinical data and tissue samples is available. (The use of data and samples without consent is only possible if exemption is granted by the corresponding Institutional Review Board - IRB).
- Histologically confirmed diagnosis of biliary tract cancer (including gallbladder carcinoma [GBC] or cholangiocarcinoma [CCA]), regardless of disease stage.
- Diagnosis must have been established within the last 15 years prior to Study initiation.
- Availability of archival formalin-fixed paraffin-embedded (FFPE) tumor tissue sample, collected prior to Study inclusion at any disease stage (e.g., during surgery or in the advanced setting). For patients with de novo metastatic disease or early stage primary tumors undergoing surgery, the tissue must have been obtained before the initiation of any systemic therapy (e.g. chemotherapy) or radiotherapy. For patients with recurrent disease undergoing a new biopsy, previous treatments are allowed.
- Availability and accessibility of basic clinical information and survival data on medical records.
Key exclusion criteria (2 listed)
- Unavailability or inadequate quality (e.g., insufficient tumor content, degraded tissue) of archival FFPE tumor tissue samples for the planned immunohistochemical analysis.
- Missing or incomplete basic clinical and/or survival data in the medical record.
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 |
|---|---|---|
| No interventionNon applicable | Other | Biliary tract cancer (either GBC or CCA) |
Primary outcome
Biomarker expression level
Time frame: Up to 16 months
To evaluate the expression levels of the following biomarkers that represent potential therapeutic targets -claudin 18.2 (CLDN18.2), human epidermal growth factor receptor 2 (HER2), trophoblast cell surface antigen 2 (TROP2), programmed death-ligand 1 (PD-L1), and B7 homolog 4 (B7-H4)-in a retrospective cohort of participants with biliary tract cancer (BTC), based on immunohistochemistry (IHC) analysis.
Overall biomarker positivity rate
Time frame: Up to 16 months
To determine the overall rate of biomarker positivity for each target within the Study population, based on IHC analysis and according to predefined, validated IHC cut-off values.
Percentage of positivity
Time frame: Up to 16 months
To assess the percentage of positive tumor cells and tumor associated stromal cells expressing each biomarker, according to predefined, validated IHC cutoff values
4 secondary outcomes
Clinical outcome and biomarker expression correlation
Time frame: Up to 16 months
Biomarker expression and disease stage correlation
Time frame: Up to 16 months
Co-expression pattern correlation with clinical outcome
Time frame: Up to 16 months
CLDN18.2 analytical validation
Time frame: Up to 16 months
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 7 Apr 2026.
- Individual participant dataSharing planned: Yes. Data collected within this study will be made available to researchers after contacting the corresponding author and upon revision and approval based on scientific merit by the trial management group (which includes a qualified statistician) of a detailed proposal for their use. The data required for the approved, specified purposes and the trial protocol will be provided after the completion of a data-sharing agreement that will be set up by the study sponsor. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. Data Sharing should begin 1 month after publication of study main results and ending 5 years after article publication. Estimate timeframe for response will be within 30 days.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer (BTC), run by MedSIR.
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 5 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: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 MEDSIR (+ 34 932 214 135, contact.trials@medsir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker expression level (time frame: Up to 16 months). The study lists 3 primary outcomes in all. 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 7 Apr 2026.