<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/NCT04451460</url>
  </required_header>
  <id_info>
    <org_study_id>AnkaraSanatoryum</org_study_id>
    <nct_id>NCT04451460</nct_id>
  </id_info>
  <brief_title>Effect of Hyponatremia in Small Cell Lung Cancer</brief_title>
  <official_title>Frequency and Effect on the Prognosis of Hyponatremia During the diagnosıs in Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara City Hospital Bilkent</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>
      In this retrospective study, the investigators determined the frequency of hyponatremia in&#xD;
      small cell lung cancer and the prognosis. 126 (27%) of 466 patients were hyponatremic.&#xD;
      Hyponatremia could not be corrected in 50.8% (n=64) of hyponatremic patients. Survival was&#xD;
      found to be better in the group of whom hyponatremia was corrected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
    <description>Effect of hyponatremia according to mortality</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">466</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Hyponatremia</arm_group_label>
    <description>Hyponatremic small cell cancer patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normonatremia</arm_group_label>
    <description>Normonatremic small cell cancer patients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with SCLC between January 2012 and January 2017 in our hospital were&#xD;
        retrospectively screened&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients diagnosed with SCLC between January 2012 and January 2017 in our hospital were&#xD;
        retrospectively screened&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Over 18 age If data doesn't exist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Small cell lung cancer</keyword>
  <keyword>hyponatremia</keyword>
  <keyword>prognosis</keyword>
  <keyword>treatment</keyword>
  <keyword>biochemistry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    <mesh_term>Hyponatremia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04451460
org study id: AnkaraSanatoryum
nct id: NCT04451460
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this retrospective study, the investigators determined the frequency of hyponatremia in
      small cell lung cancer and the prognosis. 126 (27%) of 466 patients were hyponatremic.
      Hyponatremia could not be corrected in 50.8% (n=64) of hyponatremic patients. Survival was
      found to be better in the group of whom hyponatremia was corrected.
observational model: Cohort
time perspective: Retrospective
measure: Mortality
time frame: Through study completion, an average of 3 months
description: Effect of hyponatremia according to mortality
arm group label: Hyponatremia
description: Hyponatremic small cell cancer patients
arm group label: Normonatremia
description: Normonatremic small cell cancer patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Hyponatremia