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

Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy. - an Open , Multicenter, Non-interventional Clinical Trial

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03039062

Enrollment

180

Registered

2017-02-01

Start date

2016-07-31

Completion date

2017-07-31

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapeutic Toxicity, Liver Injury, Malignant Tumor

Keywords

Serum miR-122, drug-induced liver injury by chemotherapy, malignant tumor patients

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactBinghe Xu, MD,PHD

xubinghe@medmail.com86-87788826

Backup ContactQiao Li, MD

liqiaopumc@qq.com86-87788120

Outcome results