Clinical trial NCT03039062: Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy
Official title: Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy. - an Open , Multicenter, Non-interventional Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapeutic Toxicity
Malignant Tumor
Liver Injury
Keywords: Serum miR-122
drug-induced liver injury by chemotherapy
malignant tumor patients
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2017-02-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We recuit 3 groups of people: people with malignant tumor who will receive their first cycle of chemotherapy, healthy population and patients in intensive care unit

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship of serum miR-122 level and DILI or hepatic failure
timeFrame: 1 year
Secondary outcomes:
measure: Normal physiological range of miR-122 in healthy population
timeFrame: 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, ChineseAMS
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Binghe Xu, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: