Testing molecular markers to identify high-risk colorectal polyps in people with MASH

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

This project will test whether specific gene-expression markers in polyp tissue and blood can identify high-risk colorectal polyps in adults with metabolic dysfunction-associated steatohepatitis (MASH) who are having colonoscopic polyp removal.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai East Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07463287 on ClinicalTrials.gov

What this trial studies

This observational study will collect polyp tissue, residual plasma, and stored pathology slides from adults undergoing routine colonoscopic polypectomy to compare molecular features of polyps from patients with MASH versus those without fatty liver. An initial small set of samples will undergo single-cell RNA sequencing, and a larger cohort will provide plasma and paraffin sections for validation. Liver steatosis and fibrosis will be measured by FibroScan and patients will be followed every six months to link transcriptomic findings with clinical context. Statistical analyses will test whether specific transcriptional molecules in tissue or plasma mark MASH-associated high-risk polyps and could serve as diagnostic biomarkers.

Who should consider this trial

Good fit: Adults aged 18–70 with metabolic dysfunction-associated fatty liver disease (MASH) who are scheduled for colonoscopic polypectomy and can give informed consent are the ideal candidates.

Not a fit: People with other chronic liver diseases, decompensated cirrhosis, major organ failure, those outside the 18–70 age range, or those not undergoing polypectomy are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the work could lead to blood or tissue tests that help identify colorectal polyps at higher risk in people with MASH, enabling targeted surveillance or earlier treatment.

How similar studies have performed: Transcriptomic biomarker work has shown promise for colorectal neoplasia and for liver disease associations, but applying single-cell and plasma transcriptional markers specifically to MASH-associated polyps is relatively novel and not yet widely validated.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of MAFLD conforms to the "Guidelines for the Prevention and Treatment of Non-alcoholic Fatty Liver Disease" (2018 Edition);
2. Male or female patients aged 18-70 years;
3. Signed informed consent form and explanation of the specific study protocol.

Exclusion Criteria:

1. Chronic liver disease due to other etiologies (alcoholic, viral, autoimmune, drug-induced, etc.), decompensated cirrhosis, primary liver cancer;
2. Underlying diseases of other vital organs (heart, kidney, lung, etc.) and bleeding disorders;
3. Individuals lacking legal capacity or with poor insight.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ting Mao, Bachelor

Conditions MASH - Metabolic Dysfunction-Associated Steatohepatitis; colorectal polyps; MASH