Steatotic Liver DiseaseNCT07537829
Risk Factors and Prediction Model for Liver-Related Outcomes in Elderly Patients With Steatotic Liver Disease
An observational study of Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is a single-center, retrospective cohort study based on data from the Nanjing Elderly Steatotic Liver Disease Cohort. The study aims to investigate risk factors for liver-related adverse outcomes (including significant fibrosis, advanced fibrosis, cirrhosis, hepatocellular carcinoma, and liver-related death) and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatotic Liver Disease
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is derived from the Nanjing Elderly Steatotic Liver Disease Cohort, which includes individuals aged ≥60 years with imaging or biopsy-confirmed hepatic steatosis. Participants underwent annual health examinations from 2018 to March 2026. Data on demographics, lifestyle, anthropometrics, laboratory tests, abdominal ultrasound, and medication use were collected. All data were retrospectively extracted from medical records and the cohort database.
Who may be able to join
- Age ≥60 years
- Presence of hepatic steatosis confirmed by baseline imaging (e.g., ultrasound, transient elastography) or liver biopsy
Who cannot join
- Missing data for key variables
- Pre-existing hepatocellular carcinoma or history of liver transplantation at baseline
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu
About this study
Official title: Risk Factors and Prediction Model for Liver-Related Adverse Outcomes in Elderly Patients With Steatotic Liver Disease
This is a single-center, retrospective cohort study based on data from the Nanjing Elderly Steatotic Liver Disease Cohort. The study aims to investigate risk factors for liver-related adverse outcomes (including significant fibrosis, advanced fibrosis, cirrhosis, hepatocellular carcinoma, and liver-related death) and extrahepatic outcomes (new-onset type 2 diabetes, chronic kidney disease, and cardiovascular disease) in elderly patients (aged ≥60 years) with steatotic liver disease. A total of approximately 10,000 participants will be included. Baseline and annual follow-up data on demographics, lifestyle, anthropometric measurements, laboratory tests, abdominal ultrasound, and medication use will be collected. Risk prediction models will be developed using machine learning algorithms. The study is observational and does not involve any intervention.
Read the detailed description
Background: Steatotic liver disease (SLD) is highly prevalent among the elderly and can progress to cirrhosis and hepatocellular carcinoma. However, large-scale longitudinal studies focusing on risk prediction in Chinese elderly populations are limited.
Objectives: Primary objective is to identify risk factors and develop a prediction model for significant fibrosis. Secondary objectives include models for advanced fibrosis, cirrhosis, hepatocellular carcinoma, liver-related death, and extrahepatic outcomes (type 2 diabetes, chronic kidney disease, cardiovascular disease), as well as comparison of outcomes across SLD subtypes (MASLD, MetALD, ALD).
Methods: This is a single-center, retrospective cohort study using data from the Nanjing Elderly Steatotic Liver Disease Cohort (initiated in 2018). Approximately 10,000 participants aged ≥60 years with imaging or biopsy-proven hepatic steatosis will be included. Baseline and annual follow-up data include demographics, lifestyle factors (smoking, alcohol, diet, physical activity), anthropometric measurements, laboratory tests (glucose, lipids, liver and kidney function), abdominal ultrasound, and medication use. The primary outcome is significant fibrosis (FIB-4 ≥2.67); secondary outcomes include advanced fibrosis, cirrhosis, hepatocellular carcinoma, liver-related death, and extrahepatic outcomes. Cox regression will be used for univariate and multivariate analyses. Machine learning algorithms (random forest, XGBoost, Cox-boost) will be applied to develop prediction models, with performance evaluated by time-dependent ROC curves, calibration curves, and decision curve analysis. A competing risk model will account for death as a competing event. The study has been approved by the Ethics Committee of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
- Keywords
- Steatotic Liver Disease, Elderly, Risk Factors, Prediction Model, Liver Fibrosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly SLD Cohort | Elderly patients (aged ≥60 years) with steatotic liver disease (SLD) confirmed by imaging or biopsy, enrolled from the Nanjing Elderly Steatotic Liver Disease Cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Significant Fibrosis
Significant fibrosis defined as FIB-4 ≥ 2.67. Occurrence during follow-up will be assessed.
Measured: From baseline (first eligible visit) up to study completion (March 2026), assessed annually
Secondary outcomes (7)
Incidence of Advanced Fibrosis
Advanced fibrosis defined as FIB-4 ≥ 3.25.
Measured: From baseline up to March 2026, assessed annually
Incidence of Cirrhosis
Cirrhosis diagnosed by imaging (ultrasound, CT, or MRI) or liver biopsy during follow-up.
Measured: From baseline up to March 2026, assessed annually
Incidence of Hepatocellular Carcinoma (HCC)
HCC diagnosed by imaging or histopathology according to clinical guidelines.
Measured: From baseline up to March 2026, assessed annually
Liver-Related Mortality
Death attributed to liver failure, complications of cirrhosis, or hepatocellular carcinoma.
Measured: From baseline up to March 2026, assessed annually
New-Onset Type 2 Diabetes Mellitus
Defined as fasting glucose ≥126 mg/dL (7.0 mmol/L) or HbA1c ≥6.5% (48 mmol/mol) or initiation of glucose-lowering medication during follow-up.
Measured: From baseline up to March 2026, assessed annually
New-Onset Chronic Kidney Disease (CKD)
Defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m² or urine albumin-to-creatinine ratio ≥30 mg/g on two consecutive measurements.
Measured: From baseline up to March 2026, assessed annually
Incidence of Cardiovascular and Cerebrovascular Events
Composite of nonfatal myocardial infarction, coronary revascularization, stroke, or cardiovascular death.
Measured: From baseline up to March 2026, assessed annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jan 2018
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537829
- Sponsor's protocol ID
- IDD-2026-01
- Other IDs
- IDD-2026-01
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prediction Model for Liver-Related Adverse Outcomes in Elderly Patients With Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07537829
- Acronym / sponsor ID
- IDD-2026-01
- Keywords
- Steatotic Liver Disease, Elderly, Risk Factors, Prediction Model, Liver Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, retrospective cohort study based on data from the Nanjing Elderly Steatotic Liver Disease Cohort. The study aims to investigate risk factors for liver-related adverse outcomes (including significant fibrosis, advanced fibrosis, cirrhosis, hepatocellular carcinoma, and liver-related death) and extrahepatic outcomes (new-onset type 2 diabetes, chronic kidney disease, and cardiovascular disease) in elderly patients (aged ≥60 years) with steatotic liver disease. A total of approximately 10,000 participants will be included. Baseline and annual follow-up data on demographics, lifestyle, anthropometric measurements, laboratory tests, abdominal ultrasound, and medication use will be collected. Risk prediction models will be developed using machine learning algorithms. The study is observational and does not involve any intervention.
Detailed description
Background: Steatotic liver disease (SLD) is highly prevalent among the elderly and can progress to cirrhosis and hepatocellular carcinoma. However, large-scale longitudinal studies focusing on risk prediction in Chinese elderly populations are limited.
Objectives: Primary objective is to identify risk factors and develop a prediction model for significant fibrosis. Secondary objectives include models for advanced fibrosis, cirrhosis, hepatocellular carcinoma, liver-related death, and extrahepatic outcomes (type 2 diabetes, chronic kidney disease, cardiovascular disease), as well as comparison of outcomes across SLD subtypes (MASLD, MetALD, ALD).
Methods: This is a single-center, retrospective cohort study using data from the Nanjing Elderly Steatotic Liver Disease Cohort (initiated in 2018). Approximately 10,000 participants aged ≥60 years with imaging or biopsy-proven hepatic steatosis will be included. Baseline and annual follow-up data include demographics, lifestyle factors (smoking, alcohol, diet, physical activity), anthropometric measurements, laboratory tests (glucose, lipids, liver and kidney function), abdominal ultrasound, and medication use. The primary outcome is significant fibrosis (FIB-4 ≥2.67); secondary outcomes include advanced fibrosis, cirrhosis, hepatocellular carcinoma, liver-related death, and extrahepatic outcomes. Cox regression will be used for univariate and multivariate analyses. Machine learning algorithms (random forest, XGBoost, Cox-boost) will be applied to develop prediction models, with performance evaluated by time-dependent ROC curves, calibration curves, and decision curve analysis. A competing risk model will account for death as a competing event. The study has been approved by the Ethics Committee of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly SLD Cohort | – | –Elderly patients (aged ≥60 years) with steatotic liver disease (SLD) confirmed by imaging or biopsy, enrolled from the Nanjing Elderly Steatotic Liver Disease Cohort. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is derived from the Nanjing Elderly Steatotic Liver Disease Cohort, which includes individuals aged ≥60 years with imaging or biopsy-confirmed hepatic steatosis. Participants underwent annual health examinations from 2018 to March 2026. Data on demographics, lifestyle, anthropometrics, laboratory tests, abdominal ultrasound, and medication use were collected. All data were retrospectively extracted from medical records and the cohort database.
Key inclusion criteria (2 listed)
- Age ≥60 years
- Presence of hepatic steatosis confirmed by baseline imaging (e.g., ultrasound, transient elastography) or liver biopsy
Key exclusion criteria (2 listed)
- Missing data for key variables
- Pre-existing hepatocellular carcinoma or history of liver transplantation at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Significant Fibrosis
Time frame: From baseline (first eligible visit) up to study completion (March 2026), assessed annually
Significant fibrosis defined as FIB-4 ≥ 2.67. Occurrence during follow-up will be assessed.
7 secondary outcomes
Incidence of Advanced Fibrosis
Time frame: From baseline up to March 2026, assessed annually
Incidence of Cirrhosis
Time frame: From baseline up to March 2026, assessed annually
Incidence of Hepatocellular Carcinoma (HCC)
Time frame: From baseline up to March 2026, assessed annually
Liver-Related Mortality
Time frame: From baseline up to March 2026, assessed annually
New-Onset Type 2 Diabetes Mellitus
Time frame: From baseline up to March 2026, assessed annually
New-Onset Chronic Kidney Disease (CKD)
Time frame: From baseline up to March 2026, assessed annually
Incidence of Cardiovascular and Cerebrovascular Events
Time frame: From baseline up to March 2026, assessed annually
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Significant Fibrosis (time frame: From baseline (first eligible visit) up to study completion (March 2026), assessed annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.