<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03039062</url>
  </required_header>
  <id_info>
    <org_study_id>LQ003</org_study_id>
    <nct_id>NCT03039062</nct_id>
  </id_info>
  <brief_title>Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open , multicenter, interventional clinical trial to conform the role of of&#xD;
      miR-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The endorsed standard serum biomarkers, like ALT, AST, total bilirubin, are not&#xD;
      tissue-specific, and cannot detect drug-induced liver injury (DILI) at a very early stage,&#xD;
      thus unable to properly guide risk assessment and patient management. miR-122 is a&#xD;
      liver-enriched miRNA. Many studies have demonstrated that miR-122 is a sensitive and specific&#xD;
      biomarker when DILI occurred. However, there is a lack of a standard quantification method&#xD;
      for miR-122 and confirmatory studies using a comprehensive list of drugs and patients. The&#xD;
      investigators have developed the miRNA-derived Fragment Length Polymorphism (miRFLP) assay&#xD;
      for the simultaneous quantification of multiple miRNAs.The methodology improves detection&#xD;
      reliability by eliminating intra-assay variables. In this study, the investigators will&#xD;
      investigate the role of miR-122 as a real-time detection biomarker of drug-induced liver&#xD;
      injury utilizing the miRFLP assay. In addition, the investigators will try to identify the&#xD;
      normal physiological range of miR-122 in healthy population and the relationship of miR-122&#xD;
      and hepatic failure in patients of intensive care unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Relationship of serum miR-122 level and DILI or hepatic failure</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Normal physiological range of miR-122 in healthy population</measure>
    <time_frame>1 years</time_frame>
    <description>To determine a primary normal physiological range of serum miR-122 level (copies/uL) in a group of 20 healthy women and/or men.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Chemotherapeutic Toxicity</condition>
  <condition>Malignant Tumor</condition>
  <condition>Liver Injury</condition>
  <arm_group>
    <arm_group_label>Chemotherapy group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy population</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients of intensive care unit</arm_group_label>
    <description>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.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum miR-122 and serum ALT, AST,ALP and total bilirubin level&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We recuit 3 groups of people: people with malignant tumor who will receive their first&#xD;
        cycle of chemotherapy, healthy population and patients in intensive care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For all the participants:&#xD;
&#xD;
          -  Normal liver function biomarkers including ALT,AST,ALP,TBIL before recruitment.&#xD;
&#xD;
          -  Patients with liver disease:hepatitis B，hepatitis C，cirrhosis, hepatic failure and so&#xD;
             on.&#xD;
&#xD;
        For patients in chemotherapy group:&#xD;
&#xD;
          -  Life expectancy at least 12 weeks&#xD;
&#xD;
          -  40 patients received epirubicin-containing chemotherapY&#xD;
&#xD;
          -  40 patients received paclitaxel-containing chemotherapy&#xD;
&#xD;
          -  Patients received carboplatin-containing chemotherapy.&#xD;
&#xD;
          -  Patients with congestive heart failure&#xD;
&#xD;
          -  Unstable angina pectoris&#xD;
&#xD;
          -  Previous history of myocardial infarction within 6 month prior to study entry&#xD;
&#xD;
          -  Uncontrolled hypertension as determined by the Investigator or high risk uncontrolled,&#xD;
             arrhythmia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients previously received chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Binghe Xu, MD,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Binghe Xu, MD,PHD</last_name>
    <phone>86-87788826</phone>
    <email>xubinghe@medmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qiao Li, MD</last_name>
    <phone>86-87788120</phone>
    <email>liqiaopumc@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Hospital, ChineseAMS</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qiao LI, MD</last_name>
      <phone>86-10-87788120</phone>
      <email>liqiaopumc@yahoo.cn</email>
    </contact>
    <contact_backup>
      <last_name>Binghe XU, MD, PHD</last_name>
      <phone>86-10-87788495</phone>
      <email>xubinghe@medmail.com.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>March 29, 2017</last_update_submitted>
  <last_update_submitted_qc>March 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Li Qiao</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Serum miR-122</keyword>
  <keyword>drug-induced liver injury by chemotherapy</keyword>
  <keyword>malignant tumor patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Chemical and Drug Induced Liver Injury</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03039062
org study id: LQ003
nct id: NCT03039062
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Other
time perspective: Prospective
measure: Relationship of serum miR-122 level and DILI or hepatic failure
time frame: 1 year
description: 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.
measure: Normal physiological range of miR-122 in healthy population
time frame: 1 years
description: To determine a primary normal physiological range of serum miR-122 level (copies/uL) in a group of 20 healthy women and/or men.
arm group label: Chemotherapy group
description: 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.
arm group label: Healthy population
description: 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.
arm group label: Patients of intensive care unit
description: 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.
Serum miR-122 and serum ALT, AST,ALP and total bilirubin level
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Binghe Xu, MD,PHD
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Binghe Xu, MD,PHD
phone: 86-87788826
email: xubinghe@medmail.com
last name: Qiao Li, MD
phone: 86-87788120
email: liqiaopumc@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Li Qiao
investigator title: MD
mesh term: Neoplasms
mesh term: Chemical and Drug Induced Liver Injury
mesh term: Wounds and Injuries
sharing ipd: No