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

Chemotherapeutic Toxicity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03039062
• Other study ID #: LQ003
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2017
• Last updated: March 29, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: Chinese Academy of Medical Sciences
• Contact: Binghe Xu, MD,PHD
• Phone: 86-87788826
• Email: xubinghe[@]medmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity
• Drug-Induced Liver Injury
• Liver Injury
• Malignant Tumor
• Neoplasms
• Wounds and Injuries

Locations

Country	Name	City	State
China	Cancer Hospital, ChineseAMS	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of serum miR-122 level and DILI or hepatic failure	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.	1 year
Secondary	Normal physiological range of miR-122 in healthy population	To determine a primary normal physiological range of serum miR-122 level (copies/uL) in a group of 20 healthy women and/or men.	1 years