Nonalcoholic Fatty Liver DiseaseNCT03386890
Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis
An observational study of Nonalcoholic Fatty Liver Disease and Liver Steatosis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Nowadays, the morbidity of Nonalcoholic fatty liver disease (NAFLD) show ascending trend year by year, which has become an important public health problem in China. As NAFLD can progress to Non-alcoholic steatohepatitis (NASH), cirrhosis and Hepatocarcinoma, the identification and quantitative evaluation of liver… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Liver Steatosis, Liver Fibrosis
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to 31 Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NAFLD male or female patints from 18 to 65 years old,who agree with the paracentesis of liver tissue and agree to sign the informed consent form.They are accessible for regular follow-up.
Who may be able to join
- Age:18≤,≥65
- Gender:male or female
- NAFLD patient,agree with the paracentesis of liver tissue
- Regular follow-up
- Signing the Informed Consent Form
Who cannot join
- Hepatic decompensation：Including cirrhotic complications,such as ascites,hepatic encephalopathy,digestive tract bleeding,hepatorenal syndrome,spontaneous bacterial peritonitis,and HCC.
- Complications of HBV,HCV,HIV.Complications of alcoholic liver disease,autoimmune liver disease,hereditary metabolic liver disease, drug-induced liver disease and other chronic liver disease.
- AFP>100ng/ml and imaging indicates malignant occupying.Or AFP still>100ng/ml within 3 months.
- Creatinine was 1.5 times higher than the upper limit of the normal value.
- Combined with other malignant tumors(except those cured).
- Serious diseases of heart, lung, kidney, brain, blood and other important organs with dysfunction.
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- severe neurological and psychiatric diseases (such as epilepsy, depression, mania, schizophrenia, etc.)
- Pregnant women and breast-feeding women.
- The researchers consider that it is not suitable for the patients to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100000
Qianyi Wang, 86-13811629824, wangqy1001@hotmail.com
About this study
Nowadays, the morbidity of Nonalcoholic fatty liver disease (NAFLD) show ascending trend year by year, which has become an important public health problem in China. As NAFLD can progress to Non-alcoholic steatohepatitis (NASH), cirrhosis and Hepatocarcinoma, the identification and quantitative evaluation of liver steatosis and its dynamic changes are crucial. While liver biopsy is still the gold standard in the diagnosis of NAFLD, its application is limited because of the invasive procedure.The Transient Elastography(TE) combined with the Controlled Attenuation Parameter(CAP) is a new non-invasive diagnostic method for fatty liver and liver fibrosis.
In order to evaluate the diagnostic value of non-invasive assessment for the degree of liver steatosis and staging liver fibrosis, this non-invasive method will be assessed by the golden standard of liver biopsy among 400 NAFLD patients.The treatment protocols will be decided by doctor and patient both (treatment protocols and medicine are not required). Blood routine, blood biochemistry, abdominal ultrasound and Transient Elastography(TE) combined with the Controlled Attenuation Parameter(CAP) are detected during the follow-up.
- Keywords
- Non-invasive Assessment, Transient Elastography, Controlled Attenuation Parameter
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Biopsy
liver histological section
Measured: 1 year
CAP
Controlled Attenuation Parameter
Measured: 1 year
TE
Transient Elastography
Measured: 1 year
Secondary outcomes (8)
Blood routine test
Blood routine test
Measured: 1 year
liver biochemistry test
liver biochemistry test
Measured: 1 year
abdominal ultrasound
abdominal ultrasound
Measured: 1 year
electrolyte
electrolyte
Measured: 1 year
blood glucose
blood glucose
Measured: 1 year
blood lipid
blood lipid
Measured: 1 year
uric acid
uric acid
Measured: 1 year
kidney function test
kidney function test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study startDec 2015
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jidong Jia, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386890
- Sponsor's protocol ID
- XMLX201606
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tong X, Sun Y, Wang Q, Zhao X, Chen W, Zhang M, Ren Y, Zhao X, Wu X, Zhao J, Sun C, Zheng M, Ren H, Yang Z, Ou X, Jia J, You H. Delicate and thin fibrous septa indicate a regression tendency in metabolic dysfunction-associated steatohepatitis patients with advanced fibrosis. Hepatol Int. 2025 Feb;19(1):166-180. doi: 10.1007/s12072-024-10719-w. Epub 2024 Aug 16.
PubMed 39152361Wang Q, You H, Ou X, Zhao X, Sun Y, Wang M, Wang P, Wang Y, Duan W, Wang X, Wu S, Kong Y, Saxena R, Gouw ASH, Jia J. Non-obese histologically confirmed NASH patients with abnormal liver biochemistry have more advanced fibrosis. Hepatol Int. 2019 Nov;13(6):766-776. doi: 10.1007/s12072-019-09982-z. Epub 2019 Sep 26.
PubMed 31559605
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis
- ClinicalTrials.gov ID
- NCT03386890
- Acronym / sponsor ID
- XMLX201606
- Keywords
- Non-invasive Assessment, Transient Elastography, Controlled Attenuation Parameter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 29 Dec 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.
Nowadays, the morbidity of Nonalcoholic fatty liver disease (NAFLD) show ascending trend year by year, which has become an important public health problem in China. As NAFLD can progress to Non-alcoholic steatohepatitis (NASH), cirrhosis and Hepatocarcinoma, the identification and quantitative evaluation of liver steatosis and its dynamic changes are crucial. While liver biopsy is still the gold standard in the diagnosis of NAFLD, its application is limited because of the invasive procedure.The Transient Elastography(TE) combined with the Controlled Attenuation Parameter(CAP) is a new non-invasive diagnostic method for fatty liver and liver fibrosis.
In order to evaluate the diagnostic value of non-invasive assessment for the degree of liver steatosis and staging liver fibrosis, this non-invasive method will be assessed by the golden standard of liver biopsy among 400 NAFLD patients.The treatment protocols will be decided by doctor and patient both (treatment protocols and medicine are not required). Blood routine, blood biochemistry, abdominal ultrasound and Transient Elastography(TE) combined with the Controlled Attenuation Parameter(CAP) are detected during the follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NAFLD male or female patints from 18 to 65 years old,who agree with the paracentesis of liver tissue and agree to sign the informed consent form.They are accessible for regular follow-up.
Key inclusion criteria (5 listed)
- Age:18≤,≥65
- Gender:male or female
- NAFLD patient,agree with the paracentesis of liver tissue
- Regular follow-up
- Signing the Informed Consent Form
Key exclusion criteria (9 listed)
- Hepatic decompensation：Including cirrhotic complications,such as ascites,hepatic encephalopathy,digestive tract bleeding,hepatorenal syndrome,spontaneous bacterial peritonitis,and HCC.
- Complications of HBV,HCV,HIV.Complications of alcoholic liver disease,autoimmune liver disease,hereditary metabolic liver disease, drug-induced liver disease and other chronic liver disease.
- AFP>100ng/ml and imaging indicates malignant occupying.Or AFP still>100ng/ml within 3 months.
- Creatinine was 1.5 times higher than the upper limit of the normal value.
- Combined with other malignant tumors(except those cured).
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 Biopsy
Time frame: 1 year
liver histological section
CAP
Time frame: 1 year
Controlled Attenuation Parameter
TE
Time frame: 1 year
Transient Elastography
8 secondary outcomes
Blood routine test
Time frame: 1 year
liver biochemistry test
Time frame: 1 year
abdominal ultrasound
Time frame: 1 year
electrolyte
Time frame: 1 year
blood glucose
Time frame: 1 year
blood lipid
Time frame: 1 year
uric acid
Time frame: 1 year
kidney function test
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Derived from this study: PubMed 39152361Tong X, Sun Y, Wang Q, Zhao X, Chen W, Zhang M, Ren Y, Zhao X, Wu X, Zhao J, Sun C, Zheng M, Ren H, Yang Z, Ou X, Jia J, You H. Delicate and thin fibrous septa indicate a regression tendency in metabolic dysfunction-associated steatohepatitis patients with advanced fibrosis. Hepatol Int. 2025 Feb;19(1):166-180. doi: 10.1007/s12072-024-10719-w. Epub 2024 Aug 16.
- Derived from this study: PubMed 31559605Wang Q, You H, Ou X, Zhao X, Sun Y, Wang M, Wang P, Wang Y, Duan W, Wang X, Wu S, Kong Y, Saxena R, Gouw ASH, Jia J. Non-obese histologically confirmed NASH patients with abnormal liver biochemistry have more advanced fibrosis. Hepatol Int. 2019 Nov;13(6):766-776. doi: 10.1007/s12072-019-09982-z. Epub 2019 Sep 26.
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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.
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 Nonalcoholic Fatty Liver Disease and Liver Steatosis, run by Beijing Friendship Hospital 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 5 inclusion and 9 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 29 Dec 2017. 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 Qianyi Wang (86-13811629824, wangqy1001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Biopsy (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?
On the ClinicalTrials.gov record for NCT03386890, which also lists 2 linked publications.
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 29 Dec 2017.