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

NCT ID: NCT03039062

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-07-31

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.

Conditions

Chemotherapeutic Toxicity; Malignant Tumor; Liver Injury

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Chemotherapy group

A total of 120 malignant tumor patients who need to receive chemotherapy are involved for miR-122 detection. They are from 3 centers, 40 for each center. For the first cycle of chemotherapy, the investigators will collect 0.5-1ml blood from the remained blood sample after routine blood test during chemotherapy for each patient.Each patient will have a routine blood test before(±3 days) each cycle of chemotherapy and 7(±3)days after chemotherapy. A routine blood test will include the test of ALT,AST,ALP and TBIL. Sample collection will stop after 4 cycles of chemotherapy. All blood samples collected by investigators are the remained sample after routine tests. Patients in routine care will also have blood tests before each cycle and on day 7(+/- 3) of each cycle of chemotherapy. These patients will also have blood test at these time points even if they are not in this trial.

No interventions assigned to this group

Healthy population

Twenty healthy women or men who come to hospitals for annual physical examinations are enrolled in this study for miR-122 detection. Investigators will collect 0.5-1 ml blood from the remained blood samples after routine blood tests during their annual physical examinations.

No interventions assigned to this group

Patients of intensive care unit

Fourty patients are enrolled in this group for miR-122 detection. The investigators will collect 0.5-1ml blood from the remained blood samples of their routine blood tests or when they need blood tests.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Li Qiao

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Binghe Xu, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Binghe Xu, MD,PHD

Role: CONTACT

xubinghe@medmail.com

86-87788826

Qiao Li, MD

Role: CONTACT

liqiaopumc@qq.com

86-87788120

Facility Contacts

Qiao LI, MD

Role: primary

liqiaopumc@yahoo.cn

86-10-87788120

Binghe XU, MD, PHD

Role: backup

xubinghe@medmail.com.cn

86-10-87788495

Other Identifiers

LQ003

Identifier Type: -

Identifier Source: org_study_id