Hepatitis B / Liver Space-occupying Lesions / Patients After AblationNCT03221049
Radiomics for Diagnosing Liver Diseases and Evaluating Progression
An observational study of Hepatitis B / Liver Space-occupying Lesions / Patients After Ablation, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Liver diseases are worldwide problems. liver fibrosis and hepatocellular carcinoma are mostly concerned by clinicians. Radiomcis can improve diagnosis accuracy and evaluate disease progression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B / Liver Space-occupying Lesions / Patients After Ablation
- What is being tested?
- radiomics
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 31 Dec 2022
- 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: chronic hepatitis B patients /patients with liver space occupying lesions / patients after ablation
Who may be able to join
- HBsAg positive or HBV-DNA detected
- agreed to undergo liver biopsy
- agreed to participated in our study
- patients diagnosed with liver space occupying lesions
- with histology results of liver space occupying lesions.
- agreed to participate in our study and signed informed consent.
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- patients diagnosed with hepatocellular carcinoma;
- patients treated with ablation;
- patients performed the contrast-enhanced ultrasonography before ablation;
- patients who treated with transcatheter arterial chemoembolization (TACE) performed the contrast-enhanced ultrasonography performed before TACE;
Who cannot join
- combined with other liver disease(eg. HAV/HCV/HDV,alcoholic liver disease)
- combined with HIV
- combined with malignant liver space occupying lesions
- liver transplantation
- pregnant
- the sample size of liver biopsy could not demand: length lower than 15mm, portal areas less than 6.
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- For patients classified between benign and malignant tumor
- ultrasound images cant meet the demand for analysis
- without histology results
- For patients to estimate progression after ablation
- patients with lack of US digital imaging data
- loss to follow-up
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: the Department of Medical Ultrasonics, Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, China.
Liver diseases are worldwide problems. liver fibrosis and hepatocellular carcinoma are mostly concerned by clinicians. Radiomcis can improve diagnosis accuracy and evaluate disease progression. Hence,investors try to combine radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.
Read the detailed description
Liver diseases are worldwide problems including diffuse hepatitis disease and liver space occupying lesions. Hepatitis B virus infection is the most important one among difuse hepatitis disease. There are 240 million people infected with HBV globally, and more than one-third of these patients (approximately 93 million) live in China. For them, a precise estimation of the degree of liver fibrosis is important for estimation of prognosis, surveillance, and treatment decisions in patients with HBV infection. Hepatocellular carcinoma is usually detected in liver space occupying lesions and leading to third common death of cancer. Hence, precise diagnosis between benign and malignant tumor is of great significance. Many guidelines recommend ablation as first line treatment to small hepatocellular carcinoma, especially to those less than 1mm.
Liver biopsy has been considered the gold standard for assessing liver diseases. However, it is limited because of sample errors, interobserver variability and many complications, such as pain, bleeding and even death. CT/MR are alternative ways with high cost and complications. Ultrasound was a first optional tool to diagnose liver disease. However, there are still some problems remained to solve:first, the diagnosis accuracy of liver fibrosis remained to be improved. Second,the diagnosis performances for distinguishing benign and malignant tumor were poor. Third, there were not objective way to assess progression after liver ablations.
Radiomcis refers to the extraction and analysis of large amounts of image features from medical images. Previous studies showed that it can improve diagnosis accuracy and evaluating disease progression. Hence,we tried to combined radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.
- Being tested
- radiomics
- Keywords
- diagnosis performance, hepatocellular carcinoma, liver fibrosis, progression
- Medical subject headings
- Hepatitis B, Carcinoma, Hepatocellular, Liver Cirrhosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiomicsDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| chronic hepatitis B patients | ultrasound and radiomics Receives: Diagnostic Test: radiomics | |
| patients with liver space occupying lesions | ultrasound and radiomics Receives: Diagnostic Test: radiomics | |
| patients undergo ablation | ablation, ultrasound and radiomics Receives: Diagnostic Test: radiomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver fibrosis
the degree of liver fibrosis
Measured: 1 year
benign or malignance
the malignance of liver space occupying lesions
Measured: 5 years
The incidence of recurrence
the incidence of liver cancer recurrence after ablation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Jan 2011
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B / Liver Space-occupying Lesions / Patients After AblationStudies 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
- 3,000 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
- rongqin zheng, doctor, Principal investigator, The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221049
- Sponsor's protocol ID
- sysu2017
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2017
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Department of Medical Ultrasonics, Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, China.
- ClinicalTrials.gov ID
- NCT03221049
- Acronym / sponsor ID
- sysu2017
- Keywords
- diagnosis performance, hepatocellular carcinoma, liver fibrosis, progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jul 2017 (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.
Liver diseases are worldwide problems. liver fibrosis and hepatocellular carcinoma are mostly concerned by clinicians. Radiomcis can improve diagnosis accuracy and evaluate disease progression. Hence,investors try to combine radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.
Detailed description
Liver diseases are worldwide problems including diffuse hepatitis disease and liver space occupying lesions. Hepatitis B virus infection is the most important one among difuse hepatitis disease. There are 240 million people infected with HBV globally, and more than one-third of these patients (approximately 93 million) live in China. For them, a precise estimation of the degree of liver fibrosis is important for estimation of prognosis, surveillance, and treatment decisions in patients with HBV infection. Hepatocellular carcinoma is usually detected in liver space occupying lesions and leading to third common death of cancer. Hence, precise diagnosis between benign and malignant tumor is of great significance. Many guidelines recommend ablation as first line treatment to small hepatocellular carcinoma, especially to those less than 1mm.
Liver biopsy has been considered the gold standard for assessing liver diseases. However, it is limited because of sample errors, interobserver variability and many complications, such as pain, bleeding and even death. CT/MR are alternative ways with high cost and complications. Ultrasound was a first optional tool to diagnose liver disease. However, there are still some problems remained to solve:first, the diagnosis accuracy of liver fibrosis remained to be improved. Second,the diagnosis performances for distinguishing benign and malignant tumor were poor. Third, there were not objective way to assess progression after liver ablations.
Radiomcis refers to the extraction and analysis of large amounts of image features from medical images. Previous studies showed that it can improve diagnosis accuracy and evaluating disease progression. Hence,we tried to combined radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chronic hepatitis B patients | – | Diagnostic Test: radiomicsultrasound and radiomics |
| patients with liver space occupying lesions | – | Diagnostic Test: radiomicsultrasound and radiomics |
| patients undergo ablation | – | Diagnostic Test: radiomicsablation, ultrasound and radiomics |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- chronic hepatitis B patients /patients with liver space occupying lesions / patients after ablation
Key inclusion criteria (10 listed)
- HBsAg positive or HBV-DNA detected
- agreed to undergo liver biopsy
- agreed to participated in our study
- patients diagnosed with liver space occupying lesions
- with histology results of liver space occupying lesions.
Key exclusion criteria (12 listed)
- combined with other liver disease(eg. HAV/HCV/HDV,alcoholic liver disease)
- combined with HIV
- combined with malignant liver space occupying lesions
- liver transplantation
- pregnant
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 |
|---|---|---|
| radiomics | Diagnostic test | chronic hepatitis B patients, patients undergo ablation, patients with liver space occupying lesions |
Primary outcome
liver fibrosis
Time frame: 1 year
the degree of liver fibrosis
benign or malignance
Time frame: 5 years
the malignance of liver space occupying lesions
The incidence of recurrence
Time frame: 5 years
the incidence of liver cancer recurrence after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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.
rongqin zheng, doctor principal investigator
The department of Ultrasound, the third affiliated hospital of Sun Yat-sen 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 Hepatitis B / Liver Space-occupying Lesions / Patients After Ablation, 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 10 inclusion and 12 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 2 Sep 2021. 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 (time frame: 1 year). The study lists 3 primary outcomes in all. 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 2 Sep 2021.