Chronic Viral HepatitisHEPSCANNCT05686785
Agreement and Reliability of Transient Elastography
An observational study of Chronic Viral Hepatitis, run by Lund University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Viral Hepatitis
- What is being tested?
- Transient elastography
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic viral hepatitis, i.e. chronic hepatitis B (with or without chronic hepatitis D), of chronic hepatitis C.
Who may be able to join
- 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.
Who cannot join
- suspected or confirmed pregnancy.
- patients unable to speak Swedish
- inability to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Oskar Ljungquist
Helsingborg, Skåne County, 25187
Oskar Ljungquist, +464061000
About this study
Official title: Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study
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.
Read the detailed description
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
- Chronic Viral Hepatitis
- Being tested
- Transient elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient elastographyDiagnostic test
Also called Fibroscan
Transient elastography measures liver stiffness in kPa
| Study group | Role | What they receive |
|---|---|---|
| Chronic viral hepatitis | Not described Receives: Diagnostic Test: Transient elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95.
Disagreement, expressed as 1) the proportion of participants with inter-rater differences at or above our prespecified threshold (33%) and 2) the smallest detectable change, representing the difference needed to state with 95% certainty that a change had occurred in the underlying fibrosis (SDC95).
Measured: Assessed at a 30 min visit to the outpatient clinic
Secondary outcomes (2)
Reliability, estimated using the intra-class correlation
Reliability, for continuous stiffness measurements as well as for different fibrosis stage categories.
Measured: Assessed at a 30 min visit to the outpatient clinic
Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold.
As an exploratory outcome, patient and exam characteristics associated with inter-rater differences above our prespecified threshold of ≥ 33% in liver stiffness will be evaluated. These characteristics include patients age, hepatitis b staging, BMI, biomarkers including Alanine transaminase, probe type, (medium or XL-probe) viral load, alkaline phosphatase, bilirubin, albumin, prothrombin time/international normalized ratio, time since food (hours), time since alcohol (hours), previous liver biopsy (years)
Measured: Assessed at a 30 min visit to the outpatient clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jun 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Viral HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oskar Ljungquist, MD, PhD., Principal investigator, Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686785
- Sponsor's protocol ID
- CIV-22-08-040567
- Acronym
- HEPSCAN
- Status last verified
- Oct 2023
- First submitted
- 7 Dec 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study
- ClinicalTrials.gov ID
- NCT05686785
- Acronym / sponsor ID
- HEPSCAN / CIV-22-08-040567
- Conditions
- Chronic Viral Hepatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic viral hepatitis | – | Diagnostic Test: Transient elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic viral hepatitis, i.e. chronic hepatitis B (with or without chronic hepatitis D), of chronic hepatitis C.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- suspected or confirmed pregnancy.
- patients unable to speak Swedish
- inability to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transient elastographyAlso: FibroscanTransient elastography measures liver stiffness in kPa | Diagnostic test | Chronic viral hepatitis |
Primary outcome
Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95.
Time frame: Assessed at a 30 min visit to the outpatient clinic
Disagreement, expressed as 1) the proportion of participants with inter-rater differences at or above our prespecified threshold (33%) and 2) the smallest detectable change, representing the difference needed to state with 95% certainty that a change had occurred in the underlying fibrosis (SDC95).
2 secondary outcomes
Reliability, estimated using the intra-class correlation
Time frame: Assessed at a 30 min visit to the outpatient clinic
Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold.
Time frame: Assessed at a 30 min visit to the outpatient clinic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oskar Ljungquist, MD, PhD. principal investigator
Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Viral Hepatitis, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oskar Ljungquist, M.D, PhD (+46424061000, oskar.ljungquist@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95. (time frame: Assessed at a 30 min visit to the outpatient clinic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.