The search for biomarkers to enable detection and monitoring of disease progression along the spectrum of MASLD and MetALD: theAmsterdam MASLD aNd MetALD CoHORt (ANCHOR) study

The search for biomarkers to enable detection and monitoring of disease progression along the spectrum of MASLD and MetALD: the Amsterdam MASLD aNd MetALD CoHORt (ANCHOR) study - Amsterdam NASH cohort (ANCHOR) study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52739

Enrollment

300

Registered

2017-11-24

Start date

2018-09-24

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic dysfunction-associated steatotic liver disease

Interventions

N.A.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Diagnosis of steatosis hepatis on ultrasound or by biopsy or on Fibroscan  with CAP >280dB/m • >18 years of age • BMI >25 kg/m2

Exclusion criteria

Exclusion criteria: • Abusive alcohol use (>350 g/week for women and >420g/week for men) • Hepatitis B and/or C • Auto-immune hepatitis • Wilsons disease / alpha-1-antitripsine deficiency • Haemachromatose • Bleeding disorder, including the use of anticoagulant therapy and platelet  aggregation inhibitors. Except for subjects using platelet aggregation  inhibition monotherapy for the prevention of cardiovascular disease and without a history of any coronary events. In this case the platelet aggregation inhibitor will be discontinued for 7 days before the liver biopsy is performed. • Use of drugs with a potential role in aggravation of pre-existing MASLD  • Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.

Design outcomes

Primary

Measure	Time frame
The primary outcome is identification of new riskfactors in patients with steatosis hepatis on abdominal ultrasound that develop MASH from MASLD/MetALD. This includes study of specific hepatic gene expression (RNAseq), plasma markers (metabolites), DNA methylation, and intestinaal microbiota composition to identify rapid and slow MASLD-MASH progressors.	—

Secondary

Measure	Time frame
To apply a systems biology approach to identify the hierarchy of driving mechanisms (microbial and metabolic markers) involved in the conversion of MALSD-MASH and MASH-Cirrhosis after 5 years that can be used for the development of novel treatment options in MASH:  1. Dietary and satiety lists and excreted metabolites (24h faeces and urine) 2. Faecal and oral microbiota composition in relation to plasma metabolites in MASLD-MASH progression as well as MASH-Cirrhosis progression	—

Measure

Time frame

To apply a systems biology approach to identify the hierarchy of driving mechanisms (microbial and metabolic markers) involved in the conversion of MALSD-MASH and MASH-Cirrhosis after 5 years that can be used for the development of novel treatment options in MASH:  1. Dietary and satiety lists and excreted metabolites (24h faeces and urine) 2. Faecal and oral microbiota composition in relation to plasma metabolites in MASLD-MASH progression as well as MASH-Cirrhosis progression

—

Countries

Netherlands

Contacts

Public ContactA.G. Holleboom

Amsterdam UMC

anchor@amsterdamumc.nl0205662649

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)