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NCT04435054: NAFLD-CARE
Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.
NA trial testing Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis. in Non-Alcoholic Fatty Liver Disease in 1,000 participants. Completed in 11 September 2024.
28 October 2023
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 1,000 |
| Start date | 28 October 2020 |
| Primary completion | 28 October 2023 |
| Estimated completion | 11 September 2024 |
| Sites | 3 locations across France |
Drugs / interventions tested
- Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.
Conditions studied
- Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
Adults 40 to 80, any sex, with Non-Alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent causes of chronic liver disease worldwide. The current strategy proposed by the EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an over-referral in hepatology clinics. The proposed study will investigate the optimal strategy for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology clinics in order to reduce the over-referral to hepatology clinics.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comparison of Pathway Referrals for Liver Fibrosis Risk Stratification Performed in Diabetology and Nutrition Clinics.
Caussy C, Telliam C, Al-Nuaimi B, Maynard-Muet M, et al · · 2023 · cited 2× · PMID 37312899 · DOI 10.2147/dmso.s407511 -
Risk stratification of MASLD-related advanced fibrosis using a novel point-of-care device: the Hepatoscope.
Caussy C, Vergès B, Subtil F, Abichou-Klich A, et al · · 2026 · PMID 42107836 · DOI 10.1016/j.diabet.2026.101766
Verify or expand the search:
- PubMed search for NCT04435054
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-Alcoholic Fatty Liver Disease
Currently open trials in the same condition.
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- NCT06355310 — Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease · Phase 2 · recruiting
- NCT06863376 — Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients · Phase 2 · recruiting
Other Hospices Civils de Lyon trials
Trials by the same sponsor.
- NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
- NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
- NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
- NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
- NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04435054 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 19 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04435054.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing