NCT07816211Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 17.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 269901 (tényleges)
- Első benyújtás
- 2026. aug. 6.
- Kezdés
- 2018. jan. 1.
- Elsődleges befejezés
- 2024. dec. 1.
- Fő szponzor
- Anhui Provincial Hospital
- Betegségek
- Zsírmáj (MASLD/MASH)
- NCT-szám
- NCT07816211
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 269901
- 2018. jan. 1. és az elsődleges befejezés (2024. dec. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Explicit prior refusal by the participant (opt-out) to allow their medical or health examination data to be utilized for clinical research.
Más betegség
- Any other conditions or restrictions stipulated by the Institutional Review Board (IRB) or the hospital's data management department that preclude inclusion.
Életkor
- 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.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | Kína | Ismeretlen állapot |
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