Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in serum bile acids |
Assessed by liquid chromatography coupled with mass spectrometry. Will use descriptive statistics and graphics at baseline and 6 months, as well as study random effects regression trends from baseline to 6 months for further hypotheses generation. Results from routine clinical tests into these regression analyses, specifically those that have been shown to be strongly predictive of HCC diagnosis in prospective cohorts of cirrhosis including higher alkaline phosphatase, lower platelets, lower albumin, and lower prothrombin activity will be incorporated. Incorporated into these models will be variables representing important HCC risk factors captured through the epidemiological questionnaire, including body mass index, current alcohol use, and current dietary fat, carbohydrate, fiber, coffee, and antioxidants. Analyses will begin with univariate cross-sectional statistics for profiling the study population and bivariate tabulations as a preliminary step to possible model building. |
Baseline to 6 months |
|
Other |
Change in serum immune markers |
Assessed by proximity extension assay and next generation sequencing. Will use descriptive statistics and graphics at baseline and 6 months, as well as study random effects regression trends from baseline to 6 months for further hypotheses generation. Results from routine clinical tests into these regression analyses, specifically those that have been shown to be strongly predictive of HCC diagnosis in prospective cohorts of cirrhosis including higher alkaline phosphatase, lower platelets, lower albumin, and lower prothrombin activity will be incorporated. Incorporated into these models will be variables representing important HCC risk factors captured through the epidemiological questionnaire, including body mass index, current alcohol use, and current dietary fat, carbohydrate, fiber, coffee, and antioxidants. Analyses will begin with univariate cross-sectional statistics for profiling the study population and bivariate tabulations as a preliminary step to possible model building. |
Baseline to 6 months |
|
Primary |
Change in serum AFP-L3% |
Assessed by liquid-phase binding assay. A non-parametric two-sample Wilcoxon-Mann-Whitney test will be used to address the hypothesis. |
Baseline to 6 months |
|
Secondary |
Change in serum AFP |
Assessed by liquid-phase binding assay. Will use descriptive statistics and graphics at baseline and 6 months, as well as study random effects regression trends from baseline to 6 months for further hypotheses generation. Results from routine clinical tests into these regression analyses, specifically those that have been shown to be strongly predictive of hepatocellular carcinoma (HCC) diagnosis in prospective cohorts of cirrhosis including higher alkaline phosphatase, lower platelets, lower albumin, and lower prothrombin activity will be incorporated. Incorporated into these models will be variables representing important HCC risk factors captured through the epidemiological questionnaire, including body mass index, current alcohol use, and current dietary fat, carbohydrate, fiber, coffee, and antioxidants. Analyses will begin with univariate cross-sectional statistics for profiling the study population and bivariate tabulations as a preliminary step to possible model building. |
Baseline to 6 months |
|
Secondary |
Change in serum IL-6 |
Assessed by proximity extension assay and next generation sequencing. Will use descriptive statistics and graphics at baseline and 6 months, as well as study random effects regression trends from baseline to 6 months for further hypotheses generation. Results from routine clinical tests into these regression analyses, specifically those that have been shown to be strongly predictive of HCC diagnosis in prospective cohorts of cirrhosis including higher alkaline phosphatase, lower platelets, lower albumin, and lower prothrombin activity will be incorporated. Incorporated into these models will be variables representing important HCC risk factors captured through the epidemiological questionnaire, including body mass index, current alcohol use, and current dietary fat, carbohydrate, fiber, coffee, and antioxidants. Analyses will begin with univariate cross-sectional statistics for profiling the study population and bivariate tabulations as a preliminary step to possible model building. |
Baseline to 6 months |
|
Secondary |
Change in serum deoxycholic acid |
Assessed by liquid chromatography coupled with mass spectrometry. Will use descriptive statistics and graphics at baseline and 6 months, as well as study random effects regression trends from baseline to 6 months for further hypotheses generation. Results from routine clinical tests into these regression analyses, specifically those that have been shown to be strongly predictive of HCC diagnosis in prospective cohorts of cirrhosis including higher alkaline phosphatase, lower platelets, lower albumin, and lower prothrombin activity will be incorporated. Incorporated into these models will be variables representing important HCC risk factors captured through the epidemiological questionnaire, including body mass index, current alcohol use, and current dietary fat, carbohydrate, fiber, coffee, and antioxidants. Analyses will begin with univariate cross-sectional statistics for profiling the study population and bivariate tabulations as a preliminary step to possible model building. |
Baseline to 6 months |
|
Secondary |
Change in liver stiffness |
Assessed by liver elastography. Will use descriptive statistics and graphics at baseline and 6 months, as well as study random effects regression trends from baseline to 6 months for further hypotheses generation. Results from routine clinical tests into these regression analyses, specifically those that have been shown to be strongly predictive of HCC diagnosis in prospective cohorts of cirrhosis including higher alkaline phosphatase, lower platelets, lower albumin, and lower prothrombin activity will be incorporated. Incorporated into these models will be variables representing important HCC risk factors captured through the epidemiological questionnaire, including body mass index, current alcohol use, and current dietary fat, carbohydrate, fiber, coffee, and antioxidants. Analyses will begin with univariate cross-sectional statistics for profiling the study population and bivariate tabulations as a preliminary step to possible model building. |
Baseline to 6 months |
|
Secondary |
Change in fibrosis 4 index score |
Will use descriptive statistics and graphics at baseline and 6 months, as well as study random effects regression trends from baseline to 6 months for further hypotheses generation. Results from routine clinical tests into these regression analyses, specifically those that have been shown to be strongly predictive of HCC diagnosis in prospective cohorts of cirrhosis including higher alkaline phosphatase, lower platelets, lower albumin, and lower prothrombin activity will be incorporated. Incorporated into these models will be variables representing important HCC risk factors captured through the epidemiological questionnaire, including body mass index, current alcohol use, and current dietary fat, carbohydrate, fiber, coffee, and antioxidants. Analyses will begin with univariate cross-sectional statistics for profiling the study population and bivariate tabulations as a preliminary step to possible model building. |
Baseline to 6 months |
|
Secondary |
Change in Model for End-Stage Liver Disease score |
Will use descriptive statistics and graphics at baseline and 6 months, as well as study random effects regression trends from baseline to 6 months for further hypotheses generation. Results from routine clinical tests into these regression analyses, specifically those that have been shown to be strongly predictive of HCC diagnosis in prospective cohorts of cirrhosis including higher alkaline phosphatase, lower platelets, lower albumin, and lower prothrombin activity will be incorporated. Incorporated into these models will be variables representing important HCC risk factors captured through the epidemiological questionnaire, including body mass index, current alcohol use, and current dietary fat, carbohydrate, fiber, coffee, and antioxidants. Analyses will begin with univariate cross-sectional statistics for profiling the study population and bivariate tabulations as a preliminary step to possible model building. |
Baseline to 6 months |
|