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

Last updated: March 29, 2017
Sponsor: Chinese Academy of Medical Sciences
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Neoplasms

Genitourinary Cancer

Treatment

N/A

Clinical Study ID

NCT03039062
LQ003
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 soon. 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

Exclusion Criteria:

  • Patients previously received chemotherapy

Study Design

Total Participants: 180
Study Start date:
July 01, 2016
Estimated Completion Date:
July 31, 2017

Study 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.

Connect with a study center

  • Cancer Hospital, ChineseAMS

    Beijing, Beijing 100021
    China

    Active - Recruiting

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