Clinical trial · Observational
A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER
NCT07515950CI-TRIAL-00107504REVEAL-BTCnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer (BTC) | Malignant Biliary Tract Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biliary tract cancer (either GBC or CCA)
- description
- 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).
- interventionNames
- Other: No intervention
Primary outcomes (3)
- measure
- Biomarker expression level
- timeFrame
- Up to 16 months
- description
- 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.
- measure
- Overall biomarker positivity rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.