- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07675525
Deep Learning for Liver Fibrosis Triage in MASLD Using Longitudinal Electronic Health Records (NIMIT-AI)
NIMIT-AI: Neural Inference for Metabolic-liver Integrated Trajectories: Leveraging Deep Learning to Enhance Reliability in MASLD Triage
This study looks at a new computer program called NIMIT-AI (Neural Inference for Metabolic-liver Integrated Trajectories, Artificial Intelligence) that helps doctors find liver scarring early in patients with fatty liver disease.
Fatty liver disease, also called metabolic dysfunction-associated steatotic liver disease (MASLD), is a common condition where fat builds up in the liver. Over time, this can cause scarring (fibrosis). Finding scarring early helps doctors treat it before it gets worse.
Right now, doctors use a blood test score called FIB-4 to check for scarring. But this score misses many patients and cannot be calculated when blood test results are incomplete.
NIMIT-AI works differently. It reads a patient's blood test results over multiple visits, not just one visit, to spot patterns that suggest liver scarring. It was tested on 969 patients seen at Siriraj Hospital in Bangkok, Thailand between 2018 and 2022.
In testing, NIMIT-AI found liver scarring more accurately than FIB-4. It also worked even when some blood test results were missing, which happens often in real clinics.
This study did not ask patients to do anything extra. It used health records that were already collected as part of regular care.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok
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Bangkok Noi, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years at index visit
- Confirmed MASLD diagnosis per Delphi consensus criteria
- At least one outpatient visit with concurrent laboratory data and FibroScan liver stiffness measurement within observation window (2018-2022)
- Receiving care at Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University
Exclusion Criteria:
- Alternative chronic liver disease aetiology (autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, haemochromatosis)
- Chronic viral hepatitis (hepatitis B or C surface antigen positivity)
- Prior liver transplantation
- Active extrahepatic malignancy at baseline
- Insufficient longitudinal data for outcome ascertainment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Primary longitudinal cohort (≥2 visits)
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NIMIT-AI, a gated recurrent unit deep learning model, analyzed serial outpatient laboratory results from electronic health records collected over a 5-year observation window (2018-2022) at Siriraj Hospital.
The model processed up to 10 sequential visits per patient using 18 clinical features including liver enzymes, metabolic markers, comorbidity flags, and medication exposures to predict liver fibrosis stage without requiring elastography.
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Singleton sensitivity analysis cohort (1 visit)
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NIMIT-AI, a gated recurrent unit deep learning model, analyzed serial outpatient laboratory results from electronic health records collected over a 5-year observation window (2018-2022) at Siriraj Hospital.
The model processed up to 10 sequential visits per patient using 18 clinical features including liver enzymes, metabolic markers, comorbidity flags, and medication exposures to predict liver fibrosis stage without requiring elastography.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Area under the receiver operating characteristic curve (AUROC) for significant fibrosis (F≥2) identification
Time Frame: Assessed at end of observation period (December 2022)
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Assessed at end of observation period (December 2022)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Sensitivity-constrained positive predictive value (PPV) for significant fibrosis (F≥2) at optimised classification threshold
Time Frame: Assessed at end of observation period (December 2022)
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Assessed at end of observation period (December 2022)
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Diagnostic performance for compensated advanced chronic liver disease (F3-F4 cACLD) reported as one-vs-rest AUROC
Time Frame: Assessed at end of observation period (December 2022)
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Assessed at end of observation period (December 2022)
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Net reclassification improvement (NRI) of NIMIT-AI versus FIB-4 at guideline-recommended threshold (1.30)
Time Frame: Assessed at end of observation period (December 2022)
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Assessed at end of observation period (December 2022)
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Integrated discrimination improvement (IDI) of NIMIT-AI versus FIB-4
Time Frame: Assessed at end of observation period (December 2022)
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Assessed at end of observation period (December 2022)
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Attention weight distribution across visit positions for temporal interpretability of NIMIT-AI predictions
Time Frame: Assessed at end of observation period (December 2022)
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Assessed at end of observation period (December 2022)
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SHAP (SHapley Additive exPlanations) feature importance values for global model interpretability across fibrosis classes
Time Frame: Assessed at end of observation period (December 2022)
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Assessed at end of observation period (December 2022)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 338/2569(SIRB1)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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