Actively Recruiting

Age: 18Years - 70Years
All Genders
ID07463287

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

Led by Shanghai East Hospital · Updated on 2026-03-11

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the molecular features of colorectal polyps in patients with metabolic dysfunction-associated steatohepatitis (MASH) compared to those without fatty liver. The study aims to identify gene expression differences and potential transcriptomic biomarkers that could indicate high-risk polyps in MASH patients. This observational study follows patients scheduled for colonoscopic polypectomy as part of their routine care. Participants will provide small portions of their polyp tissue for single-cell RNA sequencing or pathological examination, as well as residual plasma samples from routine blood tests. The study includes two groups: a control group without fatty liver and a MASH group, with detailed assessments such as FibroScan to evaluate liver steatosis and fibrosis. Tissue samples will be processed and analyzed for high-risk transcriptional molecule expression. During the study, participants will have their medical histories, liver ultrasounds, blood tests, and other examinations recorded. Follow-up occurs every six months to monitor outcomes. The main outcome measure is the expression levels of high-risk transcriptional molecules in colorectal polyp tissues. Safety monitoring includes managing risks related to blood draws and colonoscopic polypectomy, which are part of routine clinical procedures. Total participation lasts through the initial assessments and ongoing six-month follow-ups.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of metabolic dysfunction-associated fatty liver disease (MAFLD) according to the 2018 guidelines
  • Male or female patients aged 18 to 70 years
  • Signed informed consent form after explanation of the study protocol
Not Eligible

You will not qualify if you...

  • Chronic liver disease from other causes such as alcoholic, viral, autoimmune, or drug-induced liver disease
  • Decompensated cirrhosis or primary liver cancer
  • Serious diseases affecting heart, kidney, lung, or bleeding disorders
  • Individuals lacking legal capacity or with poor insight

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 days

Participants undergo assessments including liver ultrasound, elastography, and routine blood tests to categorize fatty liver status and collect plasma samples for analysis.

1 to 2 visits depending on ultrasound availability

Surveillance

Duration - 1 day

Participants scheduled for colonoscopic polypectomy have their polyp tissue collected during routine clinical procedures for molecular and pathological analysis.

1 visit (colonoscopy and tissue collection)

Trial Site Locations

Total: 1 location

1

Shanghai East Hospital

Shanghai, Shanghai Municipality, China, 200120

Actively Recruiting

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Research Team

T

Ting Mao, Bachelor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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