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NCT05301231
Omics-based Predictors of NAFLD/Potential NASH
trial testing Genomics (DNA Extraction) in Non-Alcoholic Fatty Liver Disease in 450 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | National Research Centre, Egypt |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 450 |
| Start date | 1 August 2022 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 April 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Genomics (DNA Extraction)
- Epi-genomics
- Proteomics (Glycoproteomics)
- Salivary Metabolomics
- Individualized counselling for behavioural modification
Conditions studied
- Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →
- Non Alcoholic Steatohepatitis — all drugs for Non Alcoholic Steatohepatitis →
Sponsor
National Research Centre, Egypt — full company profile →
Who can join
Adults 12 to 60, any sex, with Non-Alcoholic Fatty Liver Disease or Non Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The cascade of care for the non-alcoholic fatty liver disease (NAFLD) and its progression to non-alcoholic steatohepatitis (NASH) requires crossing the barriers for their diagnosis and treatment. The multifactorial nature of NAFLD/NASH limits their diagnosis by a single factor solely. This project aimed at developing a powerful composite marker panel based on multi-omics technologies to detect NAFLD without or with fibrosis (potential for NASH) in high-risk populations (obesity, type 2 diabetes, hypertensive, dyslipidemia). This project is an exploratory study to unrevealing the intra-heterogeneity and inter-similarities of NAFLD without and with fibrosis versus those of healthy individuals. The molecular and clinical characteristics of 450 participants (225 adults aged 30-60 years and 225 children aged 12 -18 years) will be investigated; 150 NAFLD patients without, 150 NAFLD patients with fibrosis (potential NASH) compared to 150 healthy individuals. Detection of genetic polymorphism of SNP of 10 gene variants involved with NAFLD without and with fibrosis, gene discovery and molecular diagnosis of dyslipidemia using next-generation sequencing and whole-exome sequencing (genomics), the expression level for the top 5 of 168-panel genes of plasma miRNAs (epi-genomics), the glycosylation pattern of five glycoproteins (proteomics), salivary analysis of ten microbiomes and five microbial-related metabolites (metabolomics) will be investigated. Eventually, the development of precision therapies to target NAFLD without and with fibrosis and possibly reverse fibrosis could be achieved.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05301231
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other National Research Centre, Egypt trials
Trials by the same sponsor.
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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 NCT05301231 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Research Centre, Egypt
- Last refreshed: 3 June 2022
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