High-Risk Transcriptome Molecular Prediction Study of MASH-Associated Colorectal Polyps
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorShanghai East Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Recruit inpatients scheduled for colonoscopic polypectomy, with polyp sizes of 1\~2cm.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: control group
Group B: MASH group
Trial outcomes
Primary outcomes
1
Expression Levels of High-Risk Transcriptional Molecules in Colorectal Polyp Tissues
Single-cell RNA sequencing (scRNA-seq) technology will be used to perform transcriptomic analysis on colorectal polyp tissues from enrolled patients (6 cases) to screen for differentially expressed genes associated with MASH. Subsequently, real-time quantitative polymerase chain reaction (RT-qPCR) will be used to validate the expression levels of candidate genes in polyp tissues from all patients in the cohort.
Time frame
Day1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov