An observational study in Biliary Tract Cancer (BTC), sponsored by MedSIR. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by MedSIR · Observational
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.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 244 is above the median of 160 across 67 observational studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →MedSIR is the lead sponsor of 55 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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.
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
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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