Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy

• Conditions: Liver Injury; Chemotherapeutic Toxicity; Malignant Tumor

• Registration Number: NCT03039062
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

This is an open , multicenter, interventional clinical trial to conform the role of of miR-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.

Detailed Description

The endorsed standard serum biomarkers, like ALT, AST, total bilirubin, are not tissue-specific, and cannot detect drug-induced liver injury (DILI) at a very early stage, thus unable to properly guide risk assessment and patient management. miR-122 is a liver-enriched miRNA. Many studies have demonstrated that miR-122 is a sensitive and specific biomarker when DILI occurred. However, there is a lack of a standard quantification method for miR-122 and confirmatory studies using a comprehensive list of drugs and patients. The investigators have developed the miRNA-derived Fragment Length Polymorphism (miRFLP) assay for the simultaneous quantification of multiple miRNAs.The methodology improves detection reliability by eliminating intra-assay variables. In this study, the investigators will investigate the role of miR-122 as a real-time detection biomarker of drug-induced liver injury utilizing the miRFLP assay. In addition, the investigators will try to identify the normal physiological range of miR-122 in healthy population and the relationship of miR-122 and hepatic failure in patients of intensive care unit.

Study Timeline

• Study Start: 2016-07
• Status Verified: 2017-01
• Study First Submitted: 2017-01-08
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

For all the participants:

• Normal liver function biomarkers including ALT,AST,ALP,TBIL before recruitment.
• Patients with liver disease:hepatitis B，hepatitis C，cirrhosis, hepatic failure and so on.

For patients in chemotherapy group:

• Life expectancy at least 12 weeks
• 40 patients received epirubicin-containing chemotherapY
• 40 patients received paclitaxel-containing chemotherapy
• Patients received carboplatin-containing chemotherapy.
• Patients with congestive heart failure
• Unstable angina pectoris
• Previous history of myocardial infarction within 6 month prior to study entry
• Uncontrolled hypertension as determined by the Investigator or high risk uncontrolled, arrhythmia.

Exclusion Criteria

• Patients previously received chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship of serum miR-122 level and DILI or hepatic failure	1 year	Serum miR-122 level (copies/uL) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before and after each cycle of chemotherapy, and the relationship of serum miR-122 level fluctuation and liver injury will be investigated.

Secondary Outcome Measures

Name	Time	Method
Normal physiological range of miR-122 in healthy population	1 years	To determine a primary normal physiological range of serum miR-122 level (copies/uL) in a group of 20 healthy women and/or men.

Trial Locations

Locations (1)

Cancer Hospital, ChineseAMS; 🇨🇳 Beijing, Beijing, China