<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/NCT04440722</url>
  </required_header>
  <id_info>
    <org_study_id>BICTX02</org_study_id>
    <nct_id>NCT04440722</nct_id>
  </id_info>
  <brief_title>Prospective Observational Study and Biobank CKIO</brief_title>
  <official_title>Prospective Observational Study and Biobank in All Persons Referred to Center of Gender Identity Odense University Hospital (CKIO)/Body Identity Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Prospective observational study and biobank in all persons referred to CKIO&#xD;
&#xD;
        -  Patient involvement and quality of life&#xD;
&#xD;
        -  Population characteristics regarding hormone levels, safety parameters and clinical&#xD;
           outcome before and after gender affirming hormone treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational cohort study including all patients referred to the&#xD;
      Center of Gender Identity Odense. The purpose is to follow patients yearly to observe patient&#xD;
      reported outcomes and control the quality and effects of the clinical treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    replaced by other study&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2040</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2040</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient reported outcomes (PRO)</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>Questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hormone levels</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>Blood samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety parameters</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>Blood samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>Blood pressure measured in a sitting position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>Body mass index calculated from height an weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>Body weight measured on a scale in kilogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hair cortisol</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>Hair samples 3 mm thick from the back of the head</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol metabolism</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>24 hour urine samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry</measure>
    <time_frame>Every 52 weeks</time_frame>
    <description>Forced vital capacity is measured by a spirometer</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Transgender</condition>
  <arm_group>
    <arm_group_label>Transgender individuals</arm_group_label>
    <description>All transgender individuals referred to center of gender identity Odense</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, urine, hair&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients referred til CKIO&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Individuals with gender dysforia who are referred to Center of Gender Identity&#xD;
             Odense&#xD;
&#xD;
          -  Age 18+&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        °There are no exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marianne Andersen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Endocrinology, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>November 23, 2022</last_update_submitted>
  <last_update_submitted_qc>November 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Marianne Andersen</investigator_full_name>
    <investigator_title>Consultat, Dr Med, professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04440722
org study id: BICTX02
nct id: NCT04440722
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospective observational study and biobank in all persons referred to CKIO

        -  Patient involvement and quality of life

        -  Population characteristics regarding hormone levels, safety parameters and clinical
           outcome before and after gender affirming hormone treatment.
This is a prospective observational cohort study including all patients referred to the
      Center of Gender Identity Odense. The purpose is to follow patients yearly to observe patient
      reported outcomes and control the quality and effects of the clinical treatment.
observational model: Cohort
time perspective: Prospective
measure: Patient reported outcomes (PRO)
time frame: Every 52 weeks
description: Questionnaires
measure: Hormone levels
time frame: Every 52 weeks
description: Blood samples
measure: Safety parameters
time frame: Every 52 weeks
description: Blood samples
measure: Blood pressure
time frame: Every 52 weeks
description: Blood pressure measured in a sitting position
measure: Body mass index
time frame: Every 52 weeks
description: Body mass index calculated from height an weight
measure: Body weight
time frame: Every 52 weeks
description: Body weight measured on a scale in kilogram
measure: Hair cortisol
time frame: Every 52 weeks
description: Hair samples 3 mm thick from the back of the head
measure: Cortisol metabolism
time frame: Every 52 weeks
description: 24 hour urine samples
measure: Spirometry
time frame: Every 52 weeks
description: Forced vital capacity is measured by a spirometer
arm group label: Transgender individuals
description: All transgender individuals referred to center of gender identity Odense
blood, urine, hair
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marianne Andersen, Professor
role: Principal Investigator
affiliation: Odense University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Marianne Andersen
investigator title: Consultat, Dr Med, professor
sharing ipd: Undecided