<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/NCT03824613</url>
  </required_header>
  <id_info>
    <org_study_id>2018.RCHT.97.</org_study_id>
    <nct_id>NCT03824613</nct_id>
  </id_info>
  <brief_title>Urinary miRNA in Endometrial Cancer Study</brief_title>
  <official_title>Urinary microRNA Expression in Endometrial Cancer Patients - a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Cornwall Hospitals Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Cornwall Hospitals Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective feasibility study with the addition of a retrospective cohort&#xD;
      study on the the expression of microRNA in urine in endometrial cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">March 26, 2020</completion_date>
  <primary_completion_date type="Actual">March 26, 2020</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>Accuracy of predictive value of miRNA test in detecting endometrial cancer</measure>
    <time_frame>6 months</time_frame>
    <description>To determine if miRNA can distinguish endometrial cancer patients from healthy patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation to final histology</measure>
    <time_frame>6 months</time_frame>
    <description>To determine how well miRNA correlates with final histology, i.e. can miRNA determine the subtype of endometrial cancer</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">164</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Endometrial cancer patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Patients without cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Urinary miRNA</intervention_name>
    <description>MiRNA detection in urine</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Endometrial cancer patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      miRNA in urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Endometrial cancer patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of endometrial cancer&#xD;
&#xD;
          -  Age: 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior or coexisting other malignancies&#xD;
&#xD;
          -  Autoimmune disorders (other than diabetes mellitus)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <state>Cornwal</state>
        <zip>TR13LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 26, 2021</last_update_submitted>
  <last_update_submitted_qc>February 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</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/NCT03824613
org study id: 2018.RCHT.97.
nct id: NCT03824613
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a prospective feasibility study with the addition of a retrospective cohort
      study on the the expression of microRNA in urine in endometrial cancer patients.
observational model: Case-Control
time perspective: Prospective
measure: Accuracy of predictive value of miRNA test in detecting endometrial cancer
time frame: 6 months
description: To determine if miRNA can distinguish endometrial cancer patients from healthy patients
measure: Correlation to final histology
time frame: 6 months
description: To determine how well miRNA correlates with final histology, i.e. can miRNA determine the subtype of endometrial cancer
arm group label: Endometrial cancer patients
arm group label: Control group
description: Patients without cancer
intervention type: Diagnostic Test
intervention name: Urinary miRNA
description: MiRNA detection in urine
arm group label: Control group
arm group label: Endometrial cancer patients
miRNA in urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
sharing ipd: No