Testing molecular markers to identify high-risk colorectal polyps in people with MASH
Official title: High-Risk Transcriptome Molecular Prediction Study of MASH-Associated Colorectal Polyps
Run by Shanghai East Hospital · NCT07463287 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 30, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07463287 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Shanghai East Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Ting Mao, Bachelor
- Email: 13487975691@qq.com
- Phone: 134-8797-5691
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.