A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER (REVEAL-BTC)

March 31, 2026 updated by: MedSIR
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. 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).
  2. Histologically confirmed diagnosis of biliary tract cancer (including gallbladder carcinoma [GBC] or cholangiocarcinoma [CCA]), regardless of disease stage.
  3. Diagnosis must have been established within the last 15 years prior to Study initiation.
  4. 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.
  5. Availability and accessibility of basic clinical information and survival data on medical records.

Exclusion Criteria:

  1. Unavailability or inadequate quality (e.g., insufficient tumor content, degraded tissue) of archival FFPE tumor tissue samples for the planned immunohistochemical analysis.
  2. Missing or incomplete basic clinical and/or survival data in the medical record.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Other: No intervention
Non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 16 months
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.
Up to 16 months
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
Up to 16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome and biomarker expression correlation
Time Frame: Up to 16 months
To explore the correlation between individual biomarker expression and clinical outcomes, including but not limited to overall survival (OS), in participants with BTC.
Up to 16 months
Biomarker expression and disease stage correlation
Time Frame: Up to 16 months
To investigate the relationship between biomarker expression and disease stage at the time of diagnosis.
Up to 16 months
Co-expression pattern correlation with clinical outcome
Time Frame: Up to 16 months
To evaluate the association between co-expression patterns of the studied biomarkers and clinical outcomes.
Up to 16 months
CLDN18.2 analytical validation
Time Frame: Up to 16 months
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.
Up to 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedSIR

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedOPT0046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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