Chronic HepatitisNCT02143180
Accuracy of RTE for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study
An observational study of Chronic Hepatitis, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological S stages as the gold standard. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Chronic Hepatitis
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2015
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic hepatitis
Who may be able to join
- 1. Patient has a history of chronic hepatitis on clinical diagnosis; 2. Patient undergoed liver biopsy during study time.
Who cannot join
- 1. Patient cannot receive examination due to critical condition; 2. Patient refuse the examination.
Trial locations and contacts
1 site in 1 country.
China1 site
The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
Guangzhou, Guangdong
About this study
Official title: Accuracy of Real-time Tissue Elastography for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study.
Our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological S stages as the gold standard.
- Conditions
- Chronic Hepatitis
- Keywords
- real-time tissue elastography, hepatic fibrosis
- Medical subject headings
- Hepatitis, Chronic, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Fibrosis Index (LFI)
Measured: During the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Time perspective
- Prospective
- Enrolment
- 500 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
- Investigators
- Rogqin RQ Zheng, doctor, Principal investigator, The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143180
- Sponsor's protocol ID
- ThirdSunYatSen
- Status last verified
- May 2014
- First submitted
- 16 May 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Real-time Tissue Elastography for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT02143180
- Acronym / sponsor ID
- ThirdSunYatSen
- Conditions
- Chronic Hepatitis
- Keywords
- real-time tissue elastography, hepatic fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 20 May 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.
Our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological S stages as the gold standard.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic hepatitis
Key inclusion criteria (1 listed)
- 1. Patient has a history of chronic hepatitis on clinical diagnosis; 2. Patient undergoed liver biopsy during study time.
Key exclusion criteria (1 listed)
- 1. Patient cannot receive examination due to critical condition; 2. Patient refuse the examination.
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
Liver Fibrosis Index (LFI)
Time frame: During the examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
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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.
Rogqin RQ Zheng, doctor principal investigator
The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
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 Hepatitis, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site 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 1 inclusion and 1 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 20 May 2014. 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 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?
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?
Liver Fibrosis Index (LFI) (time frame: During the examination). 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 20 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.