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

NCT03039062 | Unknown DMC

• 1 other identifier: LQ003
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapeutic Toxicity; Malignant Tumor; Liver Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Normal physiological range of miR-122 in healthy population

  1 years

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• patients received epirubicin-containing chemotherapY
• 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.

You may not qualify if:

• Patients previously received chemotherapy

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, 100021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum miR-122 and serum ALT, AST,ALP and total bilirubin level

MeSH Terms

Conditions

Neoplasms

Study Officials

• Binghe Xu, MD,PHD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu, MD,PHD

CONTACT

86-87788826; xubinghe@medmail.com

Qiao Li, MD

CONTACT

86-87788120; liqiaopumc@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 8, 2017
• First Posted: February 1, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 30, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)