LiverScreen | Clinical Study - LiverScreen
Clinical Study

The LiverScreen project will include and screen 30.000 people to validate TE as cost-effective and (clinically) feasible screening strategy for liver fibrosis detection in the general population (Figure 1), by answering the following queries:

  1. The suitability of TE for early detection of liver fibrosis in the community
  2. The stratification of the general population according to risk factors
  3. The progression of chronic liver disease
  4. The assessment of the economic feasibility of the screening  program
  5. The feasibility of a screening program in real healthcare settings
overarching_idea
Figure 1. Overarching idea of the LiverScreen project: timely detection of advanced fibrosis will allow for timely treatment and thereby save lives and increase health. All the while avoiding futile, costly investigations in patients who do not progress to significant fibrosis and cirrhosis

To address these queries in a structured manner, LiverScreen consists of three phases (Figure 2):

phases
Figure 2. Phases of the LiverScreen project

1) Data collection where 13 clinical centres will include 25.500 people in clinical studies, which willform the basis for data analysis. The data collection phase consists of two types of studies:

  1. A cross-sectional population-based screening study that will include approximately 30.000 people from the general population to screen on liver fibrosis using TE for LSM. Additionally, information on potential risk factors of subjects is collected. 21.000 out of the 30,000, will be included in the present call. Data from a current cross-sectional screening study (using the same approach and protocol) performed by the LiverScreen consortium partners including 6.721 patients will be included to increase the study size and power for analysis. This part of the study has been funded by the EIT Health via grant Number: 18258 in combination with a competitive private funding from industry).

    See algorithm attached below:

    clinical_trial_schema

  2. A longitudinal study based on previous cohorts consisting of 4.500 people that were screened for liver disease some years ago and will be re-screened using TE for LSM to gain insight in progressions of liver disease over time. Information on potential risk factors of these subjects will also be collected.

2) Data analysis where information from the cross-sectional studies and longitudinal study is integrated and analysed to analyse data from 34.500 patients to:

  1. Validate accuracy of TE by comparing the TE values with fibrosis stages by liver biopsies (the golden standard for liver disease).
  2. Stratify risk factors to confirm known and identify new risk factors associated with the prevalence of (early stage) liver disease and also to evaluate the relationship between risk factors and progression of the disease. Based on this data, a user-friendly digital tool will be developed to enable risk evaluation of individual subjects.
  3. Calculate the cost-effectiveness of a screening program to assess the economic efficiency and feasibility of the liver screening program based on TE screening with risk factor stratification

3) Implementation strategy where the output from the data collection and data analyses is utilized to develop and evaluate a liver fibrosis screening program tailored to patients with risk factors in different healthcare settings across Europe.

  1. Demonstration of the developed liver screen program will be done in four countries with different healthcare systems (social security systems versus national health system) and income (high versus low).

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