Biliary Tract Cancer (BTC)
Conditions
Keywords
Biliary tract cancer, CLDN18.2, TROP2, B7-H4, HER-2, PD-L1
Brief summary
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.
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.
Interventions
OTHERNo intervention
Non applicable
Sponsors
MedSIR
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker expression level | 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. |
| Overall biomarker positivity rate | 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. |
| Percentage of positivity | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome and biomarker expression correlation | 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. |
| Biomarker expression and disease stage correlation | Up to 16 months | To investigate the relationship between biomarker expression and disease stage at the time of diagnosis. |
| Co-expression pattern correlation with clinical outcome | Up to 16 months | To evaluate the association between co-expression patterns of the studied biomarkers and clinical outcomes. |
| CLDN18.2 analytical validation | 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. |
Contacts
CONTACTMEDSIR
Outcome results
None listed