High-Risk Transcriptome Molecular Prediction Study of MASH-Associated Colorectal Polyps (NCT07463287) | Clinical Trial Compass
RecruitingNot Applicable
High-Risk Transcriptome Molecular Prediction Study of MASH-Associated Colorectal Polyps
China100 participantsStarted 2025-04-30
Plain-language summary
The goal of this observational study is to learn about the molecular characteristics of colorectal polyps in patients with metabolic dysfunction-associated steatohepatitis (MASH) compared to individuals without fatty liver, and to identify potential transcriptomic biomarkers for high-risk polyps. The main questions it aims to answer are: What are the key gene expression differences in adenomatous polyps between MASH patients and non-fatty liver individuals? Can specific high-risk transcriptional molecules in plasma and polyp tissue serve as biomarkers for MASH-related colorectal polyps? Participants already scheduled for colonoscopic polypectomy as part of their routine care will provide a small portion of their polyp tissue, residual plasma from standard blood tests, and allow use of their stored pathological slides for research; they will also be followed up every six months.
Who can participate
Age range
18 Years – 70 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
. Diagnosis of MAFLD conforms to the "Guidelines for the Prevention and Treatment of Non-alcoholic Fatty Liver Disease" (2018 Edition);
. Male or female patients aged 18-70 years;
. Signed informed consent form and explanation of the specific study protocol.
Exclusion criteria
. Chronic liver disease due to other etiologies (alcoholic, viral, autoimmune, drug-induced, etc.), decompensated cirrhosis, primary liver cancer;
. Underlying diseases of other vital organs (heart, kidney, lung, etc.) and bleeding disorders;
. Individuals lacking legal capacity or with poor insight.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Expression Levels of High-Risk Transcriptional Molecules in Colorectal Polyp Tissues