Comparative Study of Circulating microRNA Changes in Patients With Liver Injury and Healthy Subjects

• Conditions: Drug-Induced Liver Injury; Liver Failure

• Registration Number: NCT03000621
• Lead Sponsor: University of Electronic Science and Technology of China

Brief Summary

The objectives are to:

1. validate a panel of tissue-specific miRNAs that are differentially expressed in the plasma of patients with and without liver injuries

2. investigate the physiological range of the circulating miRNA panel in Healthy Subjects and under stress

3. investigate the dysregulation of circulating miRNA panel and their prognostic and predictive values in clinical outcomes in identifying patients at high risk for mortality and acute liver failure.

This trial involves peripheral blood sampling from subjects at their earliest presentation and remaining stays in the hospitalization in the emergency department. The investigators will develop panels of miRNAs that are specific indicator of early onset of major organ failures, and correlate clinical outcomes with these miRNAs.

Detailed Description

The ICU patients after surgery or under chemotherapies in sponsor's institutes will be enrolled in this observational cohort of investigation. Whole blood samples will be separated immediately into plasma for storage. The participants will have their 2nd and 3rd samples obtained at 24-48 hours and 48-72 hours respectively. The schedule of most of sampling schedule is designed in concordance with the ICU routines to avoid extra burdens on patients. The plasma samples will be used as prognostic markers in prognostic and predictive values in identifying patients at high risk for mortality and acute liver failure. Patients who are discharged will be tracked for any clinical recurrence of the diseases every 28 days to assess the diagnostic accuracy of the miRNA biomarkers that are measured.

The 2nd objective will be assessed by measuring the concentration of miRNAs in recruited healthy volunteers before and after a brief public speech. The circulating miRNAs will be detected directly from 1 - 5 ul of plasma samples with the miRFLP assay. This capillary electrophoresis-based miRNA quantification method detects multiple miRNAs in absolute copy number in smaller sample signature with negligible batch to batch variation, thus providing a standardizable miRNA detection method.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-12
• Study First Submitted: 2016-12-17
• Study First Submitted QC: 2016-12-17
• Study First Posted: 2016-12-22
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients and their correlation with liver failure	Three years	The concentration of circulating miRNAs in absolute quantification in comparison to the severity of liver injury (control vs. liver injury vs. acute liver injury). To investigate the potential prognosis of liver failure by the expression difference of the miRNA panel at the onset of liver injury. Sensitivity, specificity and the potential scopes of selected miRNA in the miRNA panel to distinguish different severity of liver injury and against standard clinical parameters, serum amonotransferases (ALT, AST), total bilirubin measurement.

Secondary Outcome Measures

Name	Time	Method
The possible physiological range of selected miRNAs in healthy subjects and the performance metrics of the miRNA detection methodology	Three years	The concentration of circulating miRNAs in healthy subjects under resting condition and/or under stress. To investigate the potential physiological levels of the miRNA panel in healthy control as baselines.

Trial Locations

Locations (1)

University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China