Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy. - an Open , Multicenter, Non-interventional Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Relationship of serum miR-122 level and DILI or hepatic failure
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Relationship of serum miR-122 level and DILI or hepatic failure
Time Frame: 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 Outcomes
- Normal physiological range of miR-122 in healthy population(1 years)
Investigators
Li Qiao
MD
Chinese Academy of Medical Sciences