Liver FibrosesSWE PredictNCT03389152
SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases
An observational study of Liver Fibroses, run by SuperSonic Imagine.
Trial summary
This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of chronic liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibroses
- What is being tested?
- Elastography
- Type of treatment
- Medical device
- How many people
- 2,148 participants
- Where
- No sites listed yet
- Study dates
- 26 Jul 2007to 28 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 suspected or confirmed chronic liver disease of viral and/or steatotic origin, requiring a percutaneous liver biopsy, and who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease.
Who may be able to join
- Patients who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease of viral and/or steatotic origin,
- Patients who had reached the age of majority in their countries, at baseline,
- Patients with a baseline liver biopsy for histological evaluation of liver fibrosis with a length ≥ 15 mm paraffin sections (except if cirrhosis),
- Patients for whom a minimum length of clinical follow-up from baseline of 1 year had been recorded
Who cannot join
- Cause of chronic liver disease other than viral, ALD or NAFLD ( hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...)
- Any systemic, viral hepatitis and HIV co-infection
About this study
Official title: Evaluation of SWE as a Predictive Tool for Progression of Chronic Liver Diseases
This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of chronic liver disease.
- Conditions
- Liver Fibroses
- Being tested
- Elastography
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElastographyDevice
liver stiffness measurements by shear wave-based elastography
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver disease progression rate
Clinical signs of liver decompensation
Measured: Minimum of 28 days follow-up
Mortality rate
Patient's death
Measured: Minimum of 28 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start26 Jul 2007
- Primary completion9 Jan 2018
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosesStudies 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
- Retrospective
- Enrolment
- 2,148 participants (actual)
Sponsor and investigators
- Lead sponsor
- SuperSonic Imagine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bonn
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389152
- Sponsor's protocol ID
- LE3
- Acronym
- SWE Predict
- Status last verified
- Jul 2020
- First submitted
- 20 Dec 2017
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: At the end of the study, sharing of IPD will not be required.
Publications
Herrmann E, de Ledinghen V, Cassinotto C, Chu WC, Leung VY, Ferraioli G, Filice C, Castera L, Vilgrain V, Ronot M, Dumortier J, Guibal A, Pol S, Trebicka J, Jansen C, Strassburg C, Zheng R, Zheng J, Francque S, Vanwolleghem T, Vonghia L, Manesis EK, Zoumpoulis P, Sporea I, Thiele M, Krag A, Cohen-Bacrie C, Criton A, Gay J, Deffieux T, Friedrich-Rust M. Assessment of biopsy-proven liver fibrosis by two-dimensional shear wave elastography: An individual patient data-based meta-analysis. Hepatology. 2018 Jan;67(1):260-272. doi: 10.1002/hep.29179. Epub 2017 Nov 15.
PubMed 28370257Gu W, de Ledinghen V, Aube C, Krag A, Strassburg C, Castera L, Dumortier J, Friedrich-Rust M, Pol S, Grgurevic I, Zeleke Y, Praktiknjo M, Schierwagen R, Klein S, Francque S, Gottfriedova H, Sporea I, Schindler P, Rennebaum F, Brol MJ, Schulz M, Uschner FE, Fischer J, Margini C, Wang W, Delamarre A, Best J, Canbay A, Bauer DJM, Simbrunner B, Semmler G, Reiberger T, Boursier J, Rasmussen DN, Vilgrain V, Guibal A, Zeuzem S, Vassord C, Vonghia L, Senkerikova R, Popescu A, Berzigotti A, Laleman W, Thiele M, Jansen C, Trebicka J. Hepatocellular Cancer Surveillance in Patients with Advanced Chronic Liver Disease. NEJM Evid. 2024 Nov;3(11):EVIDoa2400062. doi: 10.1056/EVIDoa2400062. Epub 2024 Oct 22.
PubMed 39437136
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SWE as a Predictive Tool for Progression of Chronic Liver Diseases
- ClinicalTrials.gov ID
- NCT03389152
- Acronym / sponsor ID
- SWE Predict / LE3
- Conditions
- Liver Fibroses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,148 participants (actual)
- Lead sponsor
- SuperSonic ImagineIndustry (pharma, biotech, devices)
- Collaborators
- University of Bonn
- Study start
- 26 Jul 2007 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 3 Jan 2018 (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.
This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of chronic liver disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or confirmed chronic liver disease of viral and/or steatotic origin, requiring a percutaneous liver biopsy, and who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease.
Key inclusion criteria (4 listed)
- Patients who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease of viral and/or steatotic origin,
- Patients who had reached the age of majority in their countries, at baseline,
- Patients with a baseline liver biopsy for histological evaluation of liver fibrosis with a length ≥ 15 mm paraffin sections (except if cirrhosis),
- Patients for whom a minimum length of clinical follow-up from baseline of 1 year had been recorded
Key exclusion criteria (2 listed)
- Cause of chronic liver disease other than viral, ALD or NAFLD ( hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...)
- Any systemic, viral hepatitis and HIV co-infection
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 |
|---|---|---|
| Elastographyliver stiffness measurements by shear wave-based elastography | Device | – |
Primary outcome
Liver disease progression rate
Time frame: Minimum of 28 days follow-up
Clinical signs of liver decompensation
Mortality rate
Time frame: Minimum of 28 days follow-up
Patient's death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Background: PubMed 28370257Herrmann E, de Ledinghen V, Cassinotto C, Chu WC, Leung VY, Ferraioli G, Filice C, Castera L, Vilgrain V, Ronot M, Dumortier J, Guibal A, Pol S, Trebicka J, Jansen C, Strassburg C, Zheng R, Zheng J, Francque S, Vanwolleghem T, Vonghia L, Manesis EK, Zoumpoulis P, Sporea I, Thiele M, Krag A, Cohen-Bacrie C, Criton A, Gay J, Deffieux T, Friedrich-Rust M. Assessment of biopsy-proven liver fibrosis by two-dimensional shear wave elastography: An individual patient data-based meta-analysis. Hepatology. 2018 Jan;67(1):260-272. doi: 10.1002/hep.29179. Epub 2017 Nov 15.
- Derived from this study: PubMed 39437136Gu W, de Ledinghen V, Aube C, Krag A, Strassburg C, Castera L, Dumortier J, Friedrich-Rust M, Pol S, Grgurevic I, Zeleke Y, Praktiknjo M, Schierwagen R, Klein S, Francque S, Gottfriedova H, Sporea I, Schindler P, Rennebaum F, Brol MJ, Schulz M, Uschner FE, Fischer J, Margini C, Wang W, Delamarre A, Best J, Canbay A, Bauer DJM, Simbrunner B, Semmler G, Reiberger T, Boursier J, Rasmussen DN, Vilgrain V, Guibal A, Zeuzem S, Vassord C, Vonghia L, Senkerikova R, Popescu A, Berzigotti A, Laleman W, Thiele M, Jansen C, Trebicka J. Hepatocellular Cancer Surveillance in Patients with Advanced Chronic Liver Disease. NEJM Evid. 2024 Nov;3(11):EVIDoa2400062. doi: 10.1056/EVIDoa2400062. Epub 2024 Oct 22.
- Individual participant dataSharing planned: Undecided. At the end of the study, sharing of IPD will not be required.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibroses, run by SuperSonic Imagine.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver disease progression rate (time frame: Minimum of 28 days follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03389152, which also lists 2 linked publications.
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 27 Jul 2020.