<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/NCT01674023</url>
  </required_header>
  <id_info>
    <org_study_id>No.518</org_study_id>
    <nct_id>NCT01674023</nct_id>
  </id_info>
  <brief_title>MicroRNA Expression Profile in Human Vitreous of Patients With Various Vitreoretinal Diseases Requiring Vitrectomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyorin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyorin University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MicroRNAs are important regulators of many cellular functions but their expression profile in&#xD;
      human vitreous is still unclear. Aim of this study is to investigate microRNA expression&#xD;
      profile by PCR in human vitreous of patients with various vitreoretinal disorders and compare&#xD;
      with that of patients with macular holes which are suggested to be similar to that of healthy&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MicroRNA expression profile in human vitreous investigated by PCR</measure>
    <time_frame>1month</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>MicroRNA Expression Profile in Human Vitreous of Various Vitreoretinal Diseases</condition>
  <arm_group>
    <arm_group_label>human vitreous, human blood serum, PCR</arm_group_label>
    <description>human vitreous and blood serum sampling, PCR&#xD;
1ml of human vitreous and 3ml of human blood serum of patients with various vitreoretinal diseases</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      3ml of blood serum and 1ml of vitreous&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pateints undergoing vitrectomy for various vitreoretinal disesases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patients undergoing vitrectomy for various vitreoretinal diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previously vitrectomized eyes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kyorin University School Of Medicine</name>
      <address>
        <city>Mitakasi Sinkawa6-20-2</city>
        <state>Tokyo</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyorin University</investigator_affiliation>
    <investigator_full_name>Kazunari Hirota</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT01674023
org study id: No.518
nct id: NCT01674023
lead sponsor: 
has dmc: No
MicroRNAs are important regulators of many cellular functions but their expression profile in
      human vitreous is still unclear. Aim of this study is to investigate microRNA expression
      profile by PCR in human vitreous of patients with various vitreoretinal disorders and compare
      with that of patients with macular holes which are suggested to be similar to that of healthy
      subjects.
observational model: Case-Control
time perspective: Prospective
measure: MicroRNA expression profile in human vitreous investigated by PCR
time frame: 1month
arm group label: human vitreous, human blood serum, PCR
description: human vitreous and blood serum sampling, PCR
1ml of human vitreous and 3ml of human blood serum of patients with various vitreoretinal diseases
3ml of blood serum and 1ml of vitreous
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kyorin University
investigator full name: Kazunari Hirota
investigator title: MD