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NCT05712603Completed

The Nijmegen-Leiden-Amsterdam 2-tiered Care Path Study

A Care Path for the Detection of Advanced NAFLD-fibrosis: the Nijmegen-Leiden-Amsterdam 2-tiered Care Path Study - the NLA2 Study

Source: ClinicalTrials.gov · Last updated 22 Oct 2024

Brief summary (registry, in English)

Non-alcoholic fatty liver disease (NAFLD) is a liver disease, caused by storage of fat in the liver. The most-important risk-factors are being overweight, and disorders in sugar and cholesterol handling of the body. On average does around 30% of the population worldwide have any signs of fatty liver. Most people will not get severe complaints as a result of their fatty liver. But in some of them, the fat storage will lead to hepatitis. This causes damage to the liver which can eventually lead to scarring of the liver, and in some patients to cirrhosis. This possibly can cause liver failure, liver cancer, an several complaints which reduce the quality of life. There are several tests which can help in detecting scarring of the liver. However, the scientific world still does not know well enough which test works best and if they perhaps might work better if they are used together. In this study these questions will be investigated in order to design a care path which does several tests consecutively. The goal is that this will make it possible to easily detect a severely diseased liver and that this will eventually help to detect patients earlier so they can be treated earlier and complications of the disease might be reduced. Moreover, is the goal that this study will lead to a decrease in unnecessary referrals to a hepatologist, resulting in a reduction in invasive diagnostic interventions. Hospital specialists who think that their patient might be at risk for advanced liver disease, can refer a patient to this study. Participants will go to the hospital for one study visit where several tests will be done which are designed to detect liver scarring. Depending on the results, a participant will be referred to a hepatologist for more extensive diagnostics or referred back to the referring specialist with advice for management of the disease.

Status (registry)
Completed
Study type
Observational
Enrollment
655 (actual)
First submitted
19 Oct 2022
Start date
1 Oct 2022
Primary completion date
30 Jun 2024
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NCT number
NCT05712603

What you commit to

  • Study type: Observational
  • Participants enrolled: 655
  • From 1 Oct 2022 to the primary completion date, 30 Jun 2024
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous diagnosis of advanced (≥F3) liver fibrosis;
  • Drugs that may cause drug-induced hepatic steatosis, (table provided elsewhere)

Other illness

  • Any other known chronic liver disease (alcoholic steatohepatitis, hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1-antitrypsin deficiency);
  • A psychiatric, addictive or any other disorder that compromises the subject's ability to understand the study content and to give written informed consent for the participation in the study.

Other

  • Present excessive alcohol use, defined as \> 2 units/day for women and \> 3 units/day for men;

Who the study is looking for

  • Age ≥ 18 years;
  • Suspected by treating physician to suffer from a severe stage of NAFLD-fibrosis.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC, location AMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Leiden Universitair Medisch Centrum
Coordinator of this site? Confirm its status
LeidenNetherlandsUnknown status
Radboudumc
Coordinator of this site? Confirm its status
NijmegenNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.