A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое No intervention
  Non applicable

Первичные конечные точки

• Biomarker expression level [Срок оценки: Up to 16 months]
• Overall biomarker positivity rate [Срок оценки: Up to 16 months]
• Percentage of positivity [Срок оценки: Up to 16 months]

Вторичные конечные точки (4)

• Clinical outcome and biomarker expression correlation [Срок оценки: Up to 16 months]
• Biomarker expression and disease stage correlation [Срок оценки: Up to 16 months]
• Co-expression pattern correlation with clinical outcome [Срок оценки: Up to 16 months]
• CLDN18.2 analytical validation [Срок оценки: Up to 16 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07515950 · MedOPT0046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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