Liver FibrosisNCT02313649
ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
An observational study of Liver Fibrosis, run by SuperSonic Imagine at 15 sites in China.
Trial summary
This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis
- How many people
- 447 participants
- Where
- 15 sitesChina
- Study dates
- Dec 2014to Apr 2016
- 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: Chinese patients with chronic viral hepatitis B admitted for the realization of an intercostal liver biopsy in defined investigator centers.
Who may be able to join
- Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,
- Patients having reached the age of majority in China,
- Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion:
- minimal length of biopsy samples of 15 mm, stored in paraffin
- Minimal number of portal tracts of 6 per biopsy samples
- Patients of Chinese ethnic origin
Who cannot join
- Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection（Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)
- History of antiviral therapy at any time
- Any patient presenting with a co-infection of HIV
- Any patient presenting with combined liver malignant tumor
- Previous liver transplantation
- Pregnant women
- Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis…
- Any patient combined with intrahepatic cholestasis
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
People's Liberation Army General（301）Hospital
Beijing
West China Hospital, Sichuan University
Chengdu
1st Affiliated Hospital, Sun Yat-Sen University
Guangzhou
3rd Affiliated Hospital, Sun Yat-Sen University
Guangzhou
GuangZhou 8th People's Hospital
Guangzhou
1st Affiliated Hospital, Haerbin Medical University
Haerbin
1st Affiliated Hospital, ZheJiang University
Hangzhou
YunNan Province Second People's Hospital
Kunming
2nd Affiliated Hospital, Lanzhou University
Lanzhou
Jiangsu Provincial Hospital
Nanjing
Shanghai 1st People's Hospital
Shanghai
Shengjing Hospital of Chinese Medical University
Shenyang
1st Affiliated Hospital, XiAn Transportation University
Xi'an
Xijing Hospital
Xi'an
Isolation Hospital, HeNan Province
Zhengzhou
About this study
Official title: Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection
This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.
Read the detailed description
Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique.
ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis.
This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard).
The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed.
Liver stiffness measurement made by the Aixplorer will also be compared to blood markers
- Conditions
- Liver Fibrosis
- Keywords
- liver, fibrosis, elastography, ShearWave Elastography, ultrasound
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).
This will be determined by histological examination of liver biopsy
Measured: Within 12 months of the study start date
Secondary outcomes (1)
Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).
This will be determined by histological examination of liver biopsy
Measured: Within 12 months of the study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosisStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- SuperSonic Imagine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ping Liang, Principal investigator, People's Liberation Army General（301）Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313649
- Sponsor's protocol ID
- LE2
- Status last verified
- Apr 2016
- First submitted
- 8 Dec 2014
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang K, Lu X, Zhou H, Gao Y, Zheng J, Tong M, Wu C, Liu C, Huang L, Jiang T, Meng F, Lu Y, Ai H, Xie XY, Yin LP, Liang P, Tian J, Zheng R. Deep learning Radiomics of shear wave elastography significantly improved diagnostic performance for assessing liver fibrosis in chronic hepatitis B: a prospective multicentre study. Gut. 2019 Apr;68(4):729-741. doi: 10.1136/gutjnl-2018-316204. Epub 2018 May 5.
PubMed 29730602
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT02313649
- Acronym / sponsor ID
- LE2
- Conditions
- Liver Fibrosis
- Keywords
- liver, fibrosis, elastography, ShearWave Elastography, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- SuperSonic ImagineIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Dec 2014 (estimated)
- 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 will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.
Detailed description
Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique.
ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis.
This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard).
The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed.
Liver stiffness measurement made by the Aixplorer will also be compared to blood markers
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients with chronic viral hepatitis B admitted for the realization of an intercostal liver biopsy in defined investigator centers.
Key inclusion criteria (6 listed)
- Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,
- Patients having reached the age of majority in China,
- Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion:
- Patients of Chinese ethnic origin
Key exclusion criteria (8 listed)
- Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection（Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)
- History of antiviral therapy at any time
- Any patient presenting with a co-infection of HIV
- Any patient presenting with combined liver malignant tumor
- Previous liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).
Time frame: Within 12 months of the study start date
This will be determined by histological examination of liver biopsy
1 secondary outcome
Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).
Time frame: Within 12 months of the study start date
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 19 Apr 2016.
- Derived from this study: PubMed 29730602Wang K, Lu X, Zhou H, Gao Y, Zheng J, Tong M, Wu C, Liu C, Huang L, Jiang T, Meng F, Lu Y, Ai H, Xie XY, Yin LP, Liang P, Tian J, Zheng R. Deep learning Radiomics of shear wave elastography significantly improved diagnostic performance for assessing liver fibrosis in chronic hepatitis B: a prospective multicentre study. Gut. 2019 Apr;68(4):729-741. doi: 10.1136/gutjnl-2018-316204. Epub 2018 May 5.
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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.
Ping Liang principal investigator
People's Liberation Army General（301）Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis, run by SuperSonic Imagine at 15 sites in China.
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 6 inclusion and 8 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. 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?
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?
Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4). (time frame: Within 12 months of the study start date). 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 NCT02313649, which also lists 1 linked publication.
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 19 Apr 2016.