CirrhosisNCT03530657
Assessment of Liver Fibrosis and Prognosis in Chinese Patients With CHB Infection Using STE/STQ Elastography
An observational study of Cirrhosis, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
This national multicenter prospective study is aimed to study the diagnositic performance of STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cirrhosis
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2018to 1 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are recruited from primary care clinic
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 STE/STQ 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 of the conditions below will exclude patients from the study:
- Any patient presenting with combined etiologies of chronic liver diseases:，including Non hepatitis B viral infection（Hepatitis A, C, D, E）, alcoholic chronic liver disease, hemochromatosis, autoimmune hepatitis，etc
- Any patient presenting with a co-infection of HIV
- Any patient presenting with combined liver tumor
- Any patient ever received liver transplantation
- Pregnant women
- Acute hepatitis
About this study
Official title: the Department of Medical Ultrasound, Third Affiliated Hospital of Sun Yat-Sen University
This national multicenter prospective study is aimed to study the diagnositic performance of STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B infection.
Read the detailed description
Ultrasound liver elasticity measurement and imaging has not only been proposed as an alternative to evaluate the severity of chronic liver fibrosis, but also as a mean to stratify patients with advanced fibrosis according to risks of occurrence of clinical complications of end-stage liver diseases.
Sound touch elastography (STE）and sound touch quantify (STQ) developed by Mindray Resona 7 imaging system provide both two-dimensional and point shear-wave elastography of tissue elasticity with stronger penetration and easy operation.
This analysis will study the diagnositic performance of STE/STQ elastography for lver fibrosis and the prognostic value of STE/STQ elastography for the prediction of clinical complications of chronic liver diseases.
- Conditions
- Cirrhosis
- Medical subject headings
- Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Liver Fibrosis
All liver biopsies will be taken for evaluating the degree of liver fibrosis according to the METAVIRE classification. The degree of fibrosis is classified in a 0-4 scale as follows: F0: no fibrosis, F1: portal fibrosis alone, F2: portal fibrosis with rare septa, F3: portal fibrosis with many septa, and F4: cirrhosis.
Measured: 1-2 years
Secondary outcomes (1)
Complication rates depending on liver STE/STQ measurement values at baseline
Clinical complications in our study protocol are: ascites, hepatic encephalopathy, esophageal varices, fundal varices, variceal bleeding, liver failure, HCC and death. The complication rates are regarded as occurrence of clinical complications in patients with chronic hepatitis B.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start4 Jun 2018 (estimated)
- Primary completion4 Jun 2020 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rongqin Zheng, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530657
- Sponsor's protocol ID
- STE/STQ 2018
- Status last verified
- May 2018
- First submitted
- 20 Apr 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Department of Medical Ultrasound, Third Affiliated Hospital of Sun Yat-Sen University
- ClinicalTrials.gov ID
- NCT03530657
- Acronym / sponsor ID
- STE/STQ 2018
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 4 Jun 2018 (estimated)
- Primary completion
- 4 Jun 2020 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 21 May 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 national multicenter prospective study is aimed to study the diagnositic performance of STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B infection.
Detailed description
Ultrasound liver elasticity measurement and imaging has not only been proposed as an alternative to evaluate the severity of chronic liver fibrosis, but also as a mean to stratify patients with advanced fibrosis according to risks of occurrence of clinical complications of end-stage liver diseases.
Sound touch elastography (STE）and sound touch quantify (STQ) developed by Mindray Resona 7 imaging system provide both two-dimensional and point shear-wave elastography of tissue elasticity with stronger penetration and easy operation.
This analysis will study the diagnositic performance of STE/STQ elastography for lver fibrosis and the prognostic value of STE/STQ elastography for the prediction of clinical complications of chronic liver diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are recruited from primary care clinic
Key inclusion criteria (5 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 STE/STQ 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.
Key exclusion criteria (7 listed)
- Any patient presenting with combined etiologies of chronic liver diseases:，including Non hepatitis B viral infection（Hepatitis A, C, D, E）, alcoholic chronic liver disease, hemochromatosis, autoimmune hepatitis，etc
- Any patient presenting with a co-infection of HIV
- Any patient presenting with combined liver tumor
- Any patient ever received liver transplantation
- Pregnant women
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
Degree of Liver Fibrosis
Time frame: 1-2 years
All liver biopsies will be taken for evaluating the degree of liver fibrosis according to the METAVIRE classification. The degree of fibrosis is classified in a 0-4 scale as follows: F0: no fibrosis, F1: portal fibrosis alone, F2: portal fibrosis with rare septa, F3: portal fibrosis with many septa, and F4: cirrhosis.
1 secondary outcome
Complication rates depending on liver STE/STQ measurement values at baseline
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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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 Cirrhosis, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 May 2018. 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?
Results are not available in the source record.
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?
Degree of Liver Fibrosis (time frame: 1-2 years). 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 21 May 2018.