Clinical Validation of an Immunocytochemistry Method Using MARS1 (NCT04759794) | Clinical Trial Compass
CompletedNot Applicable
Clinical Validation of an Immunocytochemistry Method Using MARS1
South Korea55 participantsStarted 2021-02-04
Plain-language summary
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to validate the clinical usefulness of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer-related protein expressed only in bile duct cancer.
Who can participate
Age range
19 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:
* Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)
* Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy
* Patients who underwent surgical treatment with biliary cancer
* Patients with bile duct stenosis
Exclusion Criteria:
* Minors under the age of 19, vulnerable subjects such as illiteracy
* Necrotic specimens
* Samples with non-diagnostic cytology results and insufficient cells for further evaluation
* Samples classified as neoplastic (benign or other)
* Patient with cholangitis in the bile duct
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.
1This trial tested a new staining method called MARS1 immunocytochemistry for diagnosing extrahepatic bile duct obstruction — how does this approach compare to the diagnostic tests I've already had or might have next?
2Since this trial is completed, has the MARS1 staining method been shown to be accurate or useful enough that it's being used in clinical practice, or is it still considered experimental?
3Could the results of this completed trial affect how my own tissue or cell samples might be analyzed, and should I ask for this type of staining to be included in my workup?
4If MARS1 immunocytochemistry isn't yet widely available, what are the current standard methods being used to diagnose my bile duct obstruction, and are there any limitations to those methods I should know about?
5Is there any reason you would recommend I seek out a center that participated in this trial or has access to the MARS1 staining technique as part of my diagnostic evaluation?
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.