A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER
ConditionBiliary Tract Cancer (BTC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedSIR
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
No intervention
Other interventionNon applicable
Treatment groups
244 Participants
are divided into 1 treatment groupGroup A: Biliary tract cancer (either GBC or CCA)1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MedSIR
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov
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