Non-alcoholic Fatty Liver DiseaseNCT03842748
Non-invasive Diagnostic Model of Liver Fibrosis Associated With NAFLD and Prediction of Prognosis
An observational study of Non-alcoholic Fatty Liver Disease, run by Beijing Municipal Administration of Hospitals at 1 site in China.
Trial summary
In a retrospective study, 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fatty liver fibrosis have been identified for pathological diagnosis of liver histology and exclusion of other liver diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Dec 2021
- How long will I take part?
- 192 Weeks
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject of this study was patients with non-alcoholic fatty liver, fatty liver hepatitis and fatty liver fibrosis diagnosed by histopathology of the liver. Patients enrolled in the study excluded other liver diseases such as alcoholic fatty liver and hepatitis, viral hepatitis. , autoimmune diseases, drug-induced hepatitis and liver cancer.
Who may be able to join
- patients with non-alcoholic fatty liver, fatty liver hepatitis and fatty liver fibrosis: all meet the diagnostic criteria of China's "Guidelines for the Prevention and Treatment of Non-alcoholic Fatty Liver Diseases (2018 Update)";
- Age between 18 and over 75;
- patient were never treated with no hormones and / or immunosuppressants and other liver protection drugs.
Who cannot join
- combined with hepatitis virus infection;
- autoimmune liver disease;
- HIV infection;
- long-term alcohol abuse and / or other liver damage drugs;
- mental illness;
- Evidence of liver tumors (liver cancer or AFP > 100 ng/ml);
- decompensated cirrhosis;
- Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Minghui Li, master, 8613693259096, wuhm2000@sina.com
Minghui Li, master
About this study
Official title: Non-invasive Diagnostic Model of Liver Fibrosis Associated With Non-alcoholic Fatty Liver Disease and Prediction of Prognosis
In a retrospective study, 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fatty liver fibrosis have been identified for pathological diagnosis of liver histology and exclusion of other liver diseases. Before the liver biopsy were performed, these patients should detect liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement and imaging indicators and results, and demographic data. To evaluate the diagnostic ability of the current non-invasive diagnostic model of NAFLD fibrosis and the adaptability of model indicators to the diagnosis of enrolled patients, and to correct the indicators, including discarding unsuitable indicators and incorporating new indicators, and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD. In a prospective observational study, 100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included in the study, and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis were detected. Blood lipids, liver elasticity measurements, and imaging indicators were examined and demographic data were collected. The non-invasive diagnostic model established by retrospective study was used to diagnose fibrosis and its staging, compared with histopathological diagnosis, and adjusted the index of non-invasive diagnostic model to further revise and improve the diagnostic efficacy of the diagnostic model. Long-term follow-up observations were performed in the prospective observation cohort. The liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity and imaging examination were performed during the observation period, and the treatment events and the progress of the patients were recorded. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established.
Read the detailed description
This topic is a prospective - retrospective observational study including two parts, retrospective and prospective: in a retrospective study, 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fatty liver fibrosis have been identified for pathological diagnosis of liver histology and exclusion of other liver diseases. The liver biopsy performed in the enrolled patients included liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement and imaging indicators and results, and demographic data. To evaluate the diagnostic ability of the current non-invasive diagnostic model of NAFLD fibrosis and the adaptability of model indicators to the diagnosis of enrolled patients, and to correct the indicators, including discarding unsuitable indicators and incorporating new indicators, and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD. In a prospective observational study, 100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included in the study, and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis were included. Blood lipids, liver elasticity measurements, and imaging indicators were examined and demographic data were collected. The non-invasive diagnostic model established by retrospective study was used to diagnose fibrosis and its staging, compared with histopathological diagnosis, and adjusted the index of non-invasive diagnostic model to further improve and improve the diagnostic efficacy of the diagnostic model. Long-term follow-up observations were performed on the prospective observation cohort. The liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity and imaging examination were performed during the observation period, and the treatment events and the progress of the patients were recorded. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic, fatty liver, hepatitis, liver fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Hepatitis, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective study group | 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fibrosis have been identified for pathological diagnosis of liver histology and without other liver diseases. Before liver biopsy were performed, liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement, imaging indicators and demographic data were detected and recorded. To evaluate diagnostic ability of current non-invasive diagnostic model of NAFLD fibrosis and adaptability of model indicators to diagnosis of these patients, and correct the indicators including discarding unsuitable and incorporating new indicators and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD. | |
| Prospective observational study group | 100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included , and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis, blood lipids, liver elasticity measurements and imaging indicators were examined and demographic data were collected. Adjusted the index of non-invasive diagnostic model to further revise and improve the diagnostic efficacy of diagnostic model. Long-term follow-up observations were performed in the prospective observation cohort. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between clinical biochemical parameters of nonalcoholic fatty liver disease and pathological diagnosis of liver perforation
Correlation between clinical biochemical parameters of nonalcoholic fatty liver disease and pathological diagnosis of liver perforation, and the change of clinical biochemical parameters of nonalcoholic fatty liver disease
Measured: at baseline, 24weeks, 48weeks, 72weeks, 96weeks, 120weeks, 144weeks, 168weeks, 192weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 192 Weeks
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Minghui Li, Beijing Ditan Hospital
- Investigators
- Minghui Li, master, Principal investigator, Liver Diseases Center, Beijing Ditan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842748
- Sponsor's protocol ID
- XXZ0302
- Status last verified
- Feb 2019
- First submitted
- 19 Jan 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnostic Model of Liver Fibrosis Associated With Non-alcoholic Fatty Liver Disease and Prediction of Prognosis
- ClinicalTrials.gov ID
- NCT03842748
- Acronym / sponsor ID
- XXZ0302
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic, fatty liver, hepatitis, liver fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 15 Feb 2019 (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.
In a retrospective study, 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fatty liver fibrosis have been identified for pathological diagnosis of liver histology and exclusion of other liver diseases. Before the liver biopsy were performed, these patients should detect liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement and imaging indicators and results, and demographic data. To evaluate the diagnostic ability of the current non-invasive diagnostic model of NAFLD fibrosis and the adaptability of model indicators to the diagnosis of enrolled patients, and to correct the indicators, including discarding unsuitable indicators and incorporating new indicators, and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD. In a prospective observational study, 100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included in the study, and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis were detected. Blood lipids, liver elasticity measurements, and imaging indicators were examined and demographic data were collected. The non-invasive diagnostic model established by retrospective study was used to diagnose fibrosis and its staging, compared with histopathological diagnosis, and adjusted the index of non-invasive diagnostic model to further revise and improve the diagnostic efficacy of the diagnostic model. Long-term follow-up observations were performed in the prospective observation cohort. The liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity and imaging examination were performed during the observation period, and the treatment events and the progress of the patients were recorded. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established.
Detailed description
This topic is a prospective - retrospective observational study including two parts, retrospective and prospective: in a retrospective study, 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fatty liver fibrosis have been identified for pathological diagnosis of liver histology and exclusion of other liver diseases. The liver biopsy performed in the enrolled patients included liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement and imaging indicators and results, and demographic data. To evaluate the diagnostic ability of the current non-invasive diagnostic model of NAFLD fibrosis and the adaptability of model indicators to the diagnosis of enrolled patients, and to correct the indicators, including discarding unsuitable indicators and incorporating new indicators, and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD. In a prospective observational study, 100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included in the study, and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis were included. Blood lipids, liver elasticity measurements, and imaging indicators were examined and demographic data were collected. The non-invasive diagnostic model established by retrospective study was used to diagnose fibrosis and its staging, compared with histopathological diagnosis, and adjusted the index of non-invasive diagnostic model to further improve and improve the diagnostic efficacy of the diagnostic model. Long-term follow-up observations were performed on the prospective observation cohort. The liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity and imaging examination were performed during the observation period, and the treatment events and the progress of the patients were recorded. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 192 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective study group | – | –200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fibrosis have been identified for pathological diagnosis of liver histology and without other liver diseases. Before liver biopsy were performed, liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement, imaging indicators and demographic data were detected and recorded. To evaluate diagnostic ability of current non-invasive diagnostic model of NAFLD fibrosis and adaptability of model indicators to diagnosis of these patients, and correct the indicators including discarding unsuitable and incorporating new indicators and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD. |
| Prospective observational study group | – | –100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included , and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis, blood lipids, liver elasticity measurements and imaging indicators were examined and demographic data were collected. Adjusted the index of non-invasive diagnostic model to further revise and improve the diagnostic efficacy of diagnostic model. Long-term follow-up observations were performed in the prospective observation cohort. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject of this study was patients with non-alcoholic fatty liver, fatty liver hepatitis and fatty liver fibrosis diagnosed by histopathology of the liver. Patients enrolled in the study excluded other liver diseases such as alcoholic fatty liver and hepatitis, viral hepatitis. , autoimmune diseases, drug-induced hepatitis and liver cancer.
Key inclusion criteria (3 listed)
- patients with non-alcoholic fatty liver, fatty liver hepatitis and fatty liver fibrosis: all meet the diagnostic criteria of China's "Guidelines for the Prevention and Treatment of Non-alcoholic Fatty Liver Diseases (2018 Update)";
- Age between 18 and over 75;
- patient were never treated with no hormones and / or immunosuppressants and other liver protection drugs.
Key exclusion criteria (8 listed)
- combined with hepatitis virus infection;
- autoimmune liver disease;
- HIV infection;
- long-term alcohol abuse and / or other liver damage drugs;
- mental illness;
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
Correlation between clinical biochemical parameters of nonalcoholic fatty liver disease and pathological diagnosis of liver perforation
Time frame: at baseline, 24weeks, 48weeks, 72weeks, 96weeks, 120weeks, 144weeks, 168weeks, 192weeks.
Correlation between clinical biochemical parameters of nonalcoholic fatty liver disease and pathological diagnosis of liver perforation, and the change of clinical biochemical parameters of nonalcoholic fatty liver disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Minghui Li, master principal investigator
Liver Diseases Center, Beijing Ditan Hospital, Capital Medical 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 Non-alcoholic Fatty Liver Disease, run by Beijing Municipal Administration of Hospitals 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 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. 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?
Contact Minghui Li, master (8613693259096, wuhm2000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between clinical biochemical parameters of nonalcoholic fatty liver disease and pathological diagnosis of liver perforation (time frame: at baseline, 24weeks, 48weeks, 72weeks, 96weeks, 120weeks, 144weeks, 168weeks, 192weeks.). 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 15 Feb 2019.