NCT07816211Completed
External Transportability Validation, Implementation Readiness, and Outcome Association of the TransHepMet-Mort Liver Metabolic Mortality Risk Model
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 269901 (actual)
- First submitted
- 6 Aug 2026
- Start date
- 1 Jan 2018
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07816211
What you commit to
- Study type: Observational
- Participants enrolled: 269901
- From 1 Jan 2018 to the primary completion date, 1 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Explicit prior refusal by the participant (opt-out) to allow their medical or health examination data to be utilized for clinical research.
Other illness
- Any other conditions or restrictions stipulated by the Institutional Review Board (IRB) or the hospital's data management department that preclude inclusion.
Age
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.