<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/NCT02240966</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2013-1 75</org_study_id>
    <nct_id>NCT02240966</nct_id>
  </id_info>
  <brief_title>Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors</brief_title>
  <official_title>Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the prevalence of signs and symptoms of&#xD;
      hypogonadism in three groups of testicular cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies have shown that metabolic syndrome is common among testicular cancer. Patients&#xD;
      with low levels of testosterone appear to be at higher risk of metabolic syndrome.&#xD;
&#xD;
      A substantial number of testicular cancer survivors might be in a state of &quot;compensated&#xD;
      hypogonadism&quot; with testosterone levels low in the normal range due to an increased LH-drive&#xD;
      from the pituitary gland.&#xD;
&#xD;
      Whether this specific groups of testicular cancer survivors are at increased risk of&#xD;
      cardio-vascular disease and might benefit from testosterone substitution is yet to be&#xD;
      clarified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Metabolic Syndrome in the three groups of testicular cancer survivors according to International Diabetes Federation Guidelines and US National Cholesterol Education Program Adult Treatment Panel III criteria</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lean body mass (Kilogram)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Lean body mass assessed by DXA-scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Mineral Density (Gram/cm2)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Bone mineral density assessed by DXA-scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function (Glomerular Filtration Rate ml/min)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Renal function is assessed with 51Cr-EDTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Blood Glucose</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma-insulin</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adiponectin and leptin</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasonic appearance and size of the remaining testicle</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Ultrasonic appearance and size of the remaining of testicle assessed by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Quality of Life is assessed by the EORTC QLQ-30 Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20)</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Hypogonadism</condition>
  <condition>Cardio-vascular Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Testicular cancer survivors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Earlier treatment of testicular germ cell cancer&#xD;
&#xD;
          -  No sign of relapse &gt; 1 year since latest treatment&#xD;
&#xD;
          -  Testosterone &lt; 12 nmol/L and luteinizing hormone &gt; 8 IE/L OR&#xD;
&#xD;
          -  Testosterone &gt; 12 nmol/L and LH &gt; 8 IE/L OR&#xD;
&#xD;
          -  Testosterone and LH within their normal ranges&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Testosterone substitution&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gedske Daugaard, DMSc</last_name>
    <role>Study Director</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>July 13, 2016</last_update_submitted>
  <last_update_submitted_qc>July 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Mikkel Bandak</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Testicular Neoplasms</keyword>
  <keyword>Hypogonadism</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <keyword>Treatment related late effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Testicular Neoplasms</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Hypogonadism</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/NCT02240966
org study id: H-3-2013-1 75
nct id: NCT02240966
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the prevalence of signs and symptoms of
      hypogonadism in three groups of testicular cancer survivors.
Recent studies have shown that metabolic syndrome is common among testicular cancer. Patients
      with low levels of testosterone appear to be at higher risk of metabolic syndrome.

      A substantial number of testicular cancer survivors might be in a state of "compensated
      hypogonadism" with testosterone levels low in the normal range due to an increased LH-drive
      from the pituitary gland.

      Whether this specific groups of testicular cancer survivors are at increased risk of
      cardio-vascular disease and might benefit from testosterone substitution is yet to be
      clarified.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of Metabolic Syndrome in the three groups of testicular cancer survivors according to International Diabetes Federation Guidelines and US National Cholesterol Education Program Adult Treatment Panel III criteria
time frame: Up to 12 months
measure: Lean body mass (Kilogram)
time frame: Up to 12 months
description: Lean body mass assessed by DXA-scan
measure: Bone Mineral Density (Gram/cm2)
time frame: Up to 12 months
description: Bone mineral density assessed by DXA-scan
measure: Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide
time frame: Up to 12 months
measure: Renal function (Glomerular Filtration Rate ml/min)
time frame: Up to 12 months
description: Renal function is assessed with 51Cr-EDTA
measure: Fasting Blood Glucose
time frame: Up to 12 months
measure: plasma-insulin
time frame: Up to 12 months
measure: Adiponectin and leptin
time frame: Up to 12 months
measure: Ultrasonic appearance and size of the remaining testicle
time frame: Up to 12 months
description: Ultrasonic appearance and size of the remaining of testicle assessed by ultrasound
measure: Quality of life
time frame: Up to 12 months
description: Quality of Life is assessed by the EORTC QLQ-30 Questionnaire
measure: Anxiety and depression
time frame: Up to 12 months
description: Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS)
measure: Fatigue
time frame: Up to 12 months
description: Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gedske Daugaard, DMSc
role: Study Director
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Mikkel Bandak
investigator title: MD
mesh term: Testicular Neoplasms
mesh term: Vascular Diseases
mesh term: Cardiovascular Diseases
mesh term: Metabolic Syndrome
mesh term: Hypogonadism