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

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ClinicalTrials.gov Identifier: NCT03039062
Recruitment Status : Unknown
Verified January 2017 by Li Qiao, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : February 1, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Li Qiao, Chinese Academy of Medical Sciences

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.

Condition or disease
Chemotherapeutic Toxicity Malignant Tumor Liver Injury

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.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Other
Time Perspective: Prospective
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 Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Group/Cohort
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.



Primary Outcome Measures :
  1. Relationship of serum miR-122 level and DILI or hepatic failure [ Time Frame: 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 Outcome Measures :
  1. Normal physiological range of miR-122 in healthy population [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Serum miR-122 and serum ALT, AST,ALP and total bilirubin level


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039062


Contacts
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Contact: Binghe Xu, MD,PHD 86-87788826 xubinghe@medmail.com
Contact: Qiao Li, MD 86-87788120 liqiaopumc@qq.com

Locations
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China, Beijing
Cancer Hospital, ChineseAMS Recruiting
Beijing, Beijing, China, 100021
Contact: Qiao LI, MD    86-10-87788120    liqiaopumc@yahoo.cn   
Contact: Binghe XU, MD, PHD    86-10-87788495    xubinghe@medmail.com.cn   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Binghe Xu, MD,PHD Chinese Academy of Medical Sciences

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Responsible Party: Li Qiao, MD, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03039062     History of Changes
Other Study ID Numbers: LQ003
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Li Qiao, Chinese Academy of Medical Sciences:
Serum miR-122
drug-induced liver injury by chemotherapy
malignant tumor patients

Additional relevant MeSH terms:
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Wounds and Injuries
Neoplasms
Chemical and Drug Induced Liver Injury
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning