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

Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03000621
• Other study ID #: Uestc500
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2016
• Last updated: May 24, 2017
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: University of Electronic Science and Technology of China
• Contact: Kang Juanjuan
• Phone: + 86-28-83202351
• Email: kjj[@]immunet.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria for healthy controls:

Adults 18 years and above

Exclusion criteria for healthy controls:

Underlying chronic inflammatory condition (e.g. inflammatory bowel disease) Underlying autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus) Pre-existent liver disorder User of any prescribed medicine or over the counter drugs in prior 7 days.

Inclusion criteria for subjects:

Adults 18 years and above Has condition related to ICU enrollment cause

Exclusion criteria for subjects:

Age below 18 years Known pregnancy Treating physician deems aggressive care unsuitable Unable to provide informed consent or comply with study requirements

Related Conditions & MeSH terms

• Drug-Induced Liver Injury
• Liver Failure
• Wounds and Injuries

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (3)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China	Chengdu Nuoen Biotechnologies, Inc., Sichuan Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients and their correlation with liver failure	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.	Three years
Secondary	The possible physiological range of selected miRNAs in healthy subjects and the performance metrics of the miRNA detection methodology	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.	Three years