High-Risk Transcriptome Molecular Prediction Study of MASH-Associated Colorectal Polyps

NCT07463287 | Recruiting DMC

• 1 other identifier: Approval No.2026YS-032
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Keywords

colorectal polyps; MASH

Outcome Measures

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.

  Day1

Study Arms (2)

control group

MASH group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruit inpatients scheduled for colonoscopic polypectomy, with polyp sizes of 1\~2cm.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

colorectal polyps, serum

Central Study Contacts

Ting Mao, Bachelor

CONTACT

134-8797-5691; 13487975691@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: April 30, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

CN (1)