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NCT Number: NCT07515950

A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER

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.

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Key information

Conditions

Biliary Tract Cancer (BTC) Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

Non applicable

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

MEDSIR

CONTACT

[email protected]

+ 34 932 214 135

Sponsors and collaborators

Lead sponsor

MedSIR

Other

Collaborators

  • AstraZeneca

Registry information

Acronym: REVEAL-BTC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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