Agreement and Reliability of Transient Elastography

NCT ID: NCT05686785

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2026-12-01

Brief Summary

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The aim of this study is to assess agreement, smallest detectable change, and reliability of repeated measurements of liver stiffness of transient elastography in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Detailed Description

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Previous studies have reported excellent test-retest reliability for transient elastography (TE) in viral hepatitis. Reliability refers the ability of an instrument to discriminate between study subjects and may be excellent even if considerable measurement-error exists, if the population is heterogenous. Agreement, in contrast, refers to differences of measurements on the original scale (kPa for TE). Whether agreement is acceptable is situation-dependent and can be related to the smallest detectable change (SDC).

Agreement metrics or SDC have not been addressed in previous studies for chronic viral hepatitis. The aim of this study is to assess agreement, SDC, and reliability of repeated measurements of liver stiffness of TE in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Conditions

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Chronic Viral Hepatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic viral hepatitis

Transient elastography

Intervention Type DIAGNOSTIC_TEST

Transient elastography measures liver stiffness in kPa

Interventions

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Transient elastography

Transient elastography measures liver stiffness in kPa

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Fibroscan

Eligibility Criteria

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Inclusion Criteria

* Patients at the departments of infectious diseases in Malmö, Lund and Helsingborg with chronic viral hepatitis.
* Adult patients
* Signed informed consent to participate in the study.

Exclusion Criteria

* suspected or confirmed pregnancy.
* patients unable to speak Swedish
* inability to sign informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oskar Ljungquist, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund.

Locations

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Oskar Ljungquist

Helsingborg, Skåne County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Oskar Ljungquist, M.D, PhD

Role: CONTACT

+46424061000

Gustav Torisson, M.D, PhD

Role: CONTACT

+464033 10 00

Facility Contacts

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Oskar Ljungquist

Role: primary

+464061000

Other Identifiers

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CIV-22-08-040567

Identifier Type: -

Identifier Source: org_study_id

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