Liver FibrosisNCT02348814
Development of a Novel Biomarker for Liver Fibrosis
An observational study of Liver Fibrosis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The overall aim of this study is to validate a quantitative digital tool for staging liver fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 26 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects 18 years and older with at least one liver function test abnormality and body mass index > 20.
Who may be able to join
- Age >/= 18 years
- At least one liver function test abnormality (AST/SGOT, ALT/SOT, alkaline phosphatase, or bilirubin) defined as a value outside of the normal range at UCLA clinical labs. This must be present on at least two occasions within a 24 month consecutive period
- Any body mass index > 20
- One of the following:
- Clinical indication, according to standard of care assessment, for undergoing image-guided percutaneous (or transjugular) liver biopsy
- Eligible for weight loss (bariatric) surgery with fatty liver disease
- NAFLD/NASH patient who meets the above criteria and has already undergone a liver biopsy for diagnosis and disease staging
- NAFLD/NASH patient who meets above criteria but chooses not to participate in the liver biopsy, extra blood draws or the dietary assessment for the study.
Who cannot join
- Age < 18 years
- Current pregnancy
- Significant clinical co-morbidities that would preclude getting either a percutaneous or transjugular liver biopsy (i.e. platelets < 50, 000 or International Normalized Ratio (INR) > 1.5 or Hemoglobin < 8)
- Unwilling or unable to participate or consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Clinical and Translational Research Center (CTRC)
Los Angeles, California, 90095
About this study
The overall aim of this study is to validate a quantitative digital tool for staging liver fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in patients.
Read the detailed description
Preliminary data suggest that cholesterol and retinoid metabolism are tightly linked in these cells, prompting us to examine this relationship in the setting of obesity and diabetes. Specific aims have been developed to test the following hypotheses: 1) Quantifying liver fibrosis as a continuous variable will predict clinically significant outcomes in fatty liver disease related to metabolic syndrome; and 2) In a prospective cohort of patients, quantified liver fibrosis will correlate more strongly with tissue and circulating retinoid metabolites than with other, commonly measured serum markers.
This study offers a major innovation by performing accurate fibrosis quantification without any human intervention or post-analysis correction. In addition, we can test whether subtle differences in quantified fibrosis impact outcome for a given clinical stage of disease severity, possible because we are measuring fibrosis as a continuous variable, not a categorical one. We are using a disease-independent approach to evaluate anti-fibrotic agents in clinical trials and for evaluating other diagnostic markers.
We are also testing whether a novel diagnostic marker, retinoid storage, correlates with liver disease progression in humans. We propose to extend the study to address fatty liver disease, NAFLD/NASH, in the context of adult patients with abnormal liver tests, fatty liver identified on imaging, physical obesity, and diabetes. Clinical variables and outcomes to be recorded and analyzed include: morphology (age, gender, ethnicity, height, weight/BMI, waist circumference and steatosis on imaging studies); biochemistry (glucose intolerance or diabetes, complete blood counts, metabolic panels, liver function tests, cholesterol panels, insulin, and vitamin D levels); clinical outcomes (date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer, and death); medications (current or previous prescribed, herbals, supplements taken for diabetes, dyslipidemia, hypertension, cardiovascular disease, or stroke); and disease exacerbation/modifying factors (presence of other chronic liver diseases such as NASH + HIV, liver toxins such as alcohol consumption, weight gain, or worsening diabetes).
Data will be collected from subjects who complete eight visits over a 24-month period. Assessments will include morphometric measurements, blood collection for laboratory analysis and completion of dietary history report.
- Conditions
- Liver Fibrosis
- Keywords
- NAFLD, NASH
- Medical subject headings
- Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| normal weight | BMI 20-25 | |
| overweight | BMI 25-30 | |
| obese | BMI 30-35 | |
| morbidly obese | BMI > 35 | |
| non-diabetic | HgbA1c (<5.7%) and blood glucose (65-99 mg/dL) within normal range as defined at UCLA Clinical Lab | |
| diabetic | HgbA1c (>6.5%) and blood glucose (>100 mg/dL) as defined at UCLA Clinical Lab | |
| non-cirrhotic | Normal liver function tests (AST/SGOT, ALT, SGPT, alkaline phosphatase, bilirubin) as defined at UCLA Clinical Lab | |
| dyslipidemic | Abnormal lipid profile (Total cholesterol >170 mg/dL, LDL >100 mg/dL, HDL >130 mg/dL, triglycerides >150 mg/dL) as defined at UCLA Clinical Lab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Clinical Outcomes-change over time
Date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer (liver-related or otherwise), and death
Measured: Participants will be followed up to 24 months; measured outcomes at 8 timepoints
Secondary outcomes (1)
Composite of Morphometric Outcomes-change over time
height, weight (BMI), waist circumference, and steatosis (fat) on imaging studies
Measured: Participants will be followed up to 24 months; measured outcomes at 8 timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startMay 2015
- Primary completion26 Jan 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Beaven, University of California, Los Angeles
- Investigators
- Simon Beaven, MD/PhD, Principal investigator, UCLA Dept of Medicine, Division of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348814
- Sponsor's protocol ID
- UL1TR000124-2016
- Other IDs
- UL1TR000124
- Status last verified
- Apr 2019
- First submitted
- 14 Jan 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Biomarker for Liver Fibrosis
- ClinicalTrials.gov ID
- NCT02348814
- Acronym / sponsor ID
- UL1TR000124-2016
- Conditions
- Liver Fibrosis
- Keywords
- NAFLD, NASH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 26 Jan 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 28 Jan 2015 (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.
The overall aim of this study is to validate a quantitative digital tool for staging liver fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in patients.
Detailed description
Preliminary data suggest that cholesterol and retinoid metabolism are tightly linked in these cells, prompting us to examine this relationship in the setting of obesity and diabetes. Specific aims have been developed to test the following hypotheses: 1) Quantifying liver fibrosis as a continuous variable will predict clinically significant outcomes in fatty liver disease related to metabolic syndrome; and 2) In a prospective cohort of patients, quantified liver fibrosis will correlate more strongly with tissue and circulating retinoid metabolites than with other, commonly measured serum markers.
This study offers a major innovation by performing accurate fibrosis quantification without any human intervention or post-analysis correction. In addition, we can test whether subtle differences in quantified fibrosis impact outcome for a given clinical stage of disease severity, possible because we are measuring fibrosis as a continuous variable, not a categorical one. We are using a disease-independent approach to evaluate anti-fibrotic agents in clinical trials and for evaluating other diagnostic markers.
We are also testing whether a novel diagnostic marker, retinoid storage, correlates with liver disease progression in humans. We propose to extend the study to address fatty liver disease, NAFLD/NASH, in the context of adult patients with abnormal liver tests, fatty liver identified on imaging, physical obesity, and diabetes. Clinical variables and outcomes to be recorded and analyzed include: morphology (age, gender, ethnicity, height, weight/BMI, waist circumference and steatosis on imaging studies); biochemistry (glucose intolerance or diabetes, complete blood counts, metabolic panels, liver function tests, cholesterol panels, insulin, and vitamin D levels); clinical outcomes (date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer, and death); medications (current or previous prescribed, herbals, supplements taken for diabetes, dyslipidemia, hypertension, cardiovascular disease, or stroke); and disease exacerbation/modifying factors (presence of other chronic liver diseases such as NASH + HIV, liver toxins such as alcohol consumption, weight gain, or worsening diabetes).
Data will be collected from subjects who complete eight visits over a 24-month period. Assessments will include morphometric measurements, blood collection for laboratory analysis and completion of dietary history report.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| normal weight | – | –BMI 20-25 |
| overweight | – | –BMI 25-30 |
| obese | – | –BMI 30-35 |
| morbidly obese | – | –BMI > 35 |
| non-diabetic | – | –HgbA1c (<5.7%) and blood glucose (65-99 mg/dL) within normal range as defined at UCLA Clinical Lab |
| diabetic | – | –HgbA1c (>6.5%) and blood glucose (>100 mg/dL) as defined at UCLA Clinical Lab |
| non-cirrhotic | – | –Normal liver function tests (AST/SGOT, ALT, SGPT, alkaline phosphatase, bilirubin) as defined at UCLA Clinical Lab |
| dyslipidemic | – | –Abnormal lipid profile (Total cholesterol >170 mg/dL, LDL >100 mg/dL, HDL >130 mg/dL, triglycerides >150 mg/dL) as defined at UCLA Clinical Lab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects 18 years and older with at least one liver function test abnormality and body mass index > 20.
Key inclusion criteria (8 listed)
- Age >/= 18 years
- At least one liver function test abnormality (AST/SGOT, ALT/SOT, alkaline phosphatase, or bilirubin) defined as a value outside of the normal range at UCLA clinical labs. This must be present on at least two occasions within a 24 month consecutive period
- Any body mass index > 20
- One of the following:
- Clinical indication, according to standard of care assessment, for undergoing image-guided percutaneous (or transjugular) liver biopsy
Key exclusion criteria (4 listed)
- Age < 18 years
- Current pregnancy
- Significant clinical co-morbidities that would preclude getting either a percutaneous or transjugular liver biopsy (i.e. platelets < 50, 000 or International Normalized Ratio (INR) > 1.5 or Hemoglobin < 8)
- Unwilling or unable to participate or consent.
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
Composite of Clinical Outcomes-change over time
Time frame: Participants will be followed up to 24 months; measured outcomes at 8 timepoints
Date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer (liver-related or otherwise), and death
1 secondary outcome
Composite of Morphometric Outcomes-change over time
Time frame: Participants will be followed up to 24 months; measured outcomes at 8 timepoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Liver Fibrosis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
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.
Simon Beaven, MD/PhD principal investigator
UCLA Dept of Medicine, Division of Digestive Diseases
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 Liver Fibrosis, run by University of California, Los Angeles at 1 site in United States.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 17 Apr 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of Clinical Outcomes-change over time (time frame: Participants will be followed up to 24 months; measured outcomes at 8 timepoints). 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 17 Apr 2019.