MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)THM-ImpReadineNCT07816211
External Transportability Validation, Implementation Readiness, and Outcome Association of the TransHepMet-Mort Liver Metabolic Mortality Risk Model
An observational study of MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Study data were derived from existing electronic health records at our hospital's health examination center between January 1, 2018, and December 31, 2024. These records encompassed fatty liver-related checkups, liver ultrasound/elastography, laboratory tests, anthropometric measurements, and medical histories. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
- How many people
- 269,901 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2026
- How long will I take part?
- 24 Months
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population comprised adult participants who underwent health examinations at our hospital's health examination center between January 1, 2018, and December 31, 2024, and who possessed documented records of fatty liver disease, liver attenuation, controlled attenuation parameter (CAP), liver stiffness measurement (LSM), liver ultrasound, or related metabolic/liver function tests.For participants with multiple health examination records, the index visit was determined based on pre-specified rules. The primary definition targeted the date of the first visit where fatty liver-related examinations were available and critical variables were substantially complete. Sensitivity definitions for the index visit included: (1) the very first recorded visit, (2) the most recent recorded visit, (3) the visit with the most complete CAP/LSM data, or (4) the visit with the highest completeness of model-specific predictor variables.
Who may be able to join
- Age ≥ 18 years at the time of the health examination.
- Presence of health examination records at our hospital's health examination center between January 1, 2018, and December 31, 2024.
- Availability of fatty liver-related records, including hepatic steatosis indicated by liver ultrasound, controlled attenuation parameter (CAP), liver stiffness measurement (LSM), or screening-related checkup items.
- Complete documentation of essential baseline characteristics, minimally including age, sex, and the exact date of the physical examination.
- Possession of a unique in-hospital patient identifier or a study-specific identification code generated by the data management department to enable reliable deduplication and outcome linkage.
Who cannot join
- Age < 18 years.
- Absence of critical data fields required to establish basic eligibility, such as missing records for age, sex, or the date of the health examination.
- Presence of duplicate records that cannot be reliably resolved, or irresolvable conflicts during participant identity mapping.
- Physiologically implausible data without a verifiable audit trail for correction, such as anthropometric indices, CAP, LSM, or liver enzymes falling outside biologically reasonable ranges.
- Explicit prior refusal by the participant (opt-out) to allow their medical or health examination data to be utilized for clinical research.
- Any other conditions or restrictions stipulated by the Institutional Review Board (IRB) or the hospital's data management department that preclude inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
About this study
Official title: External Transportability Validation, Implementation Readiness, and Outcome Association of the TransHepMet-Mort Liver Metabolic Mortality Risk Model Based on Multi-Source and Hospital Health Examination Center Fatty Liver Cohorts: A Single-Center, Retrospective, Observational Study
Study data were derived from existing electronic health records at our hospital's health examination center between January 1, 2018, and December 31, 2024. These records encompassed fatty liver-related checkups, liver ultrasound/elastography, laboratory tests, anthropometric measurements, and medical histories. Following ethical approval, these datasets were linked to mortality registry, hospitalization records, and liver-related events. This study does not alter participants' past or current clinical pathways, introduces no new examination items, and requires no additional follow-up visits.Concurrently, this study serves as an external implementation evaluation of a clinical prediction model. The original model was derived from prior analyses of NHANES, CHARLS, and VCTE datasets. Rather than re-developing the primary model within the hospital data, this study focuses on evaluating the real-world implementation readiness of the existing model, conducting phenotypic validation, and performing conditional outcome verification. The application of the model within the hospital cohort is strictly limited to research purposes and will not serve as the sole baseline for clinical diagnostic or therapeutic decision-making.
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year all-cause mortality
All-cause mortality is defined as death from any cause occurring within 5 years after each participant's baseline/index assessment. Mortality status is ascertained from the available linked mortality or longitudinal follow-up data. For time-to-event analyses, follow-up is measured from the baseline/index assessment to death from any cause; participants without a documented death are censored at the last known follow-up or at 5 years, whichever occurs first.
Measured: From each participant's baseline/index assessment through 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Jan 2018
- Primary completion1 Dec 2024
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 269,901 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lianxin Liu，PhD, Anhui Provincial Hospital
- Investigators
- Jizhou Wang, MD, Study chair, The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui 230000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816211
- Sponsor's protocol ID
- 2026-RE-313
- Acronym
- THM-ImpReadine
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Transportability Validation, Implementation Readiness, and Outcome Association of the TransHepMet-Mort Liver Metabolic Mortality Risk Model Based on Multi-Source and Hospital Health Examination Center Fatty Liver Cohorts: A Single-Center, Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT07816211
- Acronym / sponsor ID
- THM-ImpReadine / 2026-RE-313
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269,901 participants (actual)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 11 Sep 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.
Study data were derived from existing electronic health records at our hospital's health examination center between January 1, 2018, and December 31, 2024. These records encompassed fatty liver-related checkups, liver ultrasound/elastography, laboratory tests, anthropometric measurements, and medical histories. Following ethical approval, these datasets were linked to mortality registry, hospitalization records, and liver-related events. This study does not alter participants' past or current clinical pathways, introduces no new examination items, and requires no additional follow-up visits.Concurrently, this study serves as an external implementation evaluation of a clinical prediction model. The original model was derived from prior analyses of NHANES, CHARLS, and VCTE datasets. Rather than re-developing the primary model within the hospital data, this study focuses on evaluating the real-world implementation readiness of the existing model, conducting phenotypic validation, and performing conditional outcome verification. The application of the model within the hospital cohort is strictly limited to research purposes and will not serve as the sole baseline for clinical diagnostic or therapeutic decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population comprised adult participants who underwent health examinations at our hospital's health examination center between January 1, 2018, and December 31, 2024, and who possessed documented records of fatty liver disease, liver attenuation, controlled attenuation parameter (CAP), liver stiffness measurement (LSM), liver ultrasound, or related metabolic/liver function tests.For participants with multiple health examination records, the index visit was determined based on pre-specified rules. The primary definition targeted the date of the first visit where fatty liver-related examinations were available and critical variables were substantially complete. Sensitivity definitions for the index visit included: (1) the very first recorded visit, (2) the most recent recorded visit, (3) the visit with the most complete CAP/LSM data, or (4) the visit with the highest completeness of model-specific predictor variables.
Key inclusion criteria (5 listed)
- Age ≥ 18 years at the time of the health examination.
- Presence of health examination records at our hospital's health examination center between January 1, 2018, and December 31, 2024.
- Availability of fatty liver-related records, including hepatic steatosis indicated by liver ultrasound, controlled attenuation parameter (CAP), liver stiffness measurement (LSM), or screening-related checkup items.
- Complete documentation of essential baseline characteristics, minimally including age, sex, and the exact date of the physical examination.
- Possession of a unique in-hospital patient identifier or a study-specific identification code generated by the data management department to enable reliable deduplication and outcome linkage.
Key exclusion criteria (6 listed)
- Age < 18 years.
- Absence of critical data fields required to establish basic eligibility, such as missing records for age, sex, or the date of the health examination.
- Presence of duplicate records that cannot be reliably resolved, or irresolvable conflicts during participant identity mapping.
- Physiologically implausible data without a verifiable audit trail for correction, such as anthropometric indices, CAP, LSM, or liver enzymes falling outside biologically reasonable ranges.
- Explicit prior refusal by the participant (opt-out) to allow their medical or health examination data to be utilized for clinical research.
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
5-year all-cause mortality
Time frame: From each participant's baseline/index assessment through 5 years of follow-up
All-cause mortality is defined as death from any cause occurring within 5 years after each participant's baseline/index assessment. Mortality status is ascertained from the available linked mortality or longitudinal follow-up data. For time-to-event analyses, follow-up is measured from the baseline/index assessment to death from any cause; participants without a documented death are censored at the last known follow-up or at 5 years, whichever occurs first.
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 Sep 2026.
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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.
Jizhou Wang, MD study chair
The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui 230000
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 MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Anhui Provincial Hospital 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 5 inclusion and 6 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 Sep 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?
5-year all-cause mortality (time frame: From each participant's baseline/index assessment through 5 years of follow-up). 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 Sep 2026.