A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Biliary Tract Cancer (BTC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other No intervention
Non applicable
Primary outcome measures
- Biomarker expression level [Time frame: Up to 16 months]
- Overall biomarker positivity rate [Time frame: Up to 16 months]
- Percentage of positivity [Time frame: Up to 16 months]
Secondary outcome measures (4)
- Clinical outcome and biomarker expression correlation [Time frame: Up to 16 months]
- Biomarker expression and disease stage correlation [Time frame: Up to 16 months]
- Co-expression pattern correlation with clinical outcome [Time frame: Up to 16 months]
- CLDN18.2 analytical validation [Time frame: Up to 16 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07515950 · MedOPT0046