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.
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
244
Non applicable
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.
Time frame: 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.
Time frame: 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
Time frame: Up to 16 months
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Up to 16 months