NCT04340817

Brief Summary

A prospective cohort study, which aims to systematically evaluate biomarkers and potential targets in NAFLD and NASH.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2017Nov 2026

Study Start

First participant enrolled

September 1, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

8 years

First QC Date

April 7, 2020

Last Update Submit

April 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fibrosis

    Number of participants with fibrosis proression

    5 years

Interventions

ProteomicsDIAGNOSTIC_TEST

Mass-spectometry proteomics

TranscriptomicsDIAGNOSTIC_TEST

Next generation sequencing

GenomicsGENETIC

Targeted genetics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators plan to include patients with suspected or verified non-alcoholic fatty liver disease

You may qualify if:

  • Non-alcoholic fatty liver disease and
  • Healthy volunteers

You may not qualify if:

  • Other liver diseases than non-alcoholic fatty liver disease
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Capital Region Denmark, 2650, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, buffy coat, liver tissue

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Genome

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Genetic StructuresGenetic Phenomena

Study Officials

  • Lise L Gluud, MD

    Copenhagen University Hospital, Hvidovre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 10, 2020

Study Start

September 1, 2017

Primary Completion

September 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations