A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER (NCT07515950) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER
244 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused on measuring biomarkers in biliary tract cancer rather than testing a new treatment, can you help me understand what they would actually do with my tissue or blood samples, and how that might or might not benefit my own care?
2This study isn't assigned a traditional phase, which suggests it's more of an observational or diagnostic study — does that mean there's no experimental treatment involved, and if so, what are the actual risks of participating?
3The trial isn't recruiting yet — given how quickly biliary tract cancer can progress, is it worth waiting to see if this opens, or should we be focused on available treatment options right now?
4If my biomarker results come back from this study, would I or my care team actually receive those results, and could they influence which treatments we consider next?
5Are there other biomarker studies or genomic profiling options already available to me today that could give us similar information without having to wait for this trial to open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.