<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/NCT04478760</url>
  </required_header>
  <id_info>
    <org_study_id>TransRIHTS Protocol</org_study_id>
    <nct_id>NCT04478760</nct_id>
  </id_info>
  <brief_title>Trans &amp; Non-binary Reference Intervals While on Hormone Therapy Study</brief_title>
  <acronym>TransRIHTS</acronym>
  <official_title>Reference Intervals for 27 Routine Chemistry and Immunoassay Tests in Transgender Adults on Stable Hormone Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College Hospital NHS 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 will find out what the reference intervals are for common blood tests in&#xD;
      transgender people taking hormone therapy.&#xD;
&#xD;
      Reference intervals help doctors interpret blood test results. They are expressed as two&#xD;
      numbers, and most normal results fall between them. If a results fall outside of them, it may&#xD;
      be because of a disease. Some blood tests are also affected by normal difference between&#xD;
      people, such as age, sex or ethnicity. For these tests, different reference intervals are&#xD;
      given for each group of people. Having accurate reference intervals benefits patients because&#xD;
      it allows doctors to identify disease faster.&#xD;
&#xD;
      Transgender people have a gender identity which does not match their sex characteristics at&#xD;
      birth. Gender identity is the feeling of being a gender, and sex is the biological aspects of&#xD;
      growing up male or female. Transgender people may use hormone therapy to help change their&#xD;
      appearance to fit their gender identity. This involves taking either oestrogen or&#xD;
      testosterone.&#xD;
&#xD;
      For blood tests which are affected by sex, it is not clear what reference intervals should be&#xD;
      used for transgender people who are on hormone therapy. This is because they have a mixture&#xD;
      of male and female sex characteristics. Answering this question will allow doctors to&#xD;
      identify disease in them faster.&#xD;
&#xD;
      The study will take place at cliniQ, at King's College Hospital, which provides health&#xD;
      services to transgender people. It will recruit healthy transgender people who attend the&#xD;
      clinic for blood tests to monitor their hormone therapy. Participants will fill out a&#xD;
      questionnaire, give a urine sample, then have their appointment as normal. Extra tests will&#xD;
      also be performed on their blood sample. The aim is to recruit 240 participants.&#xD;
      Participant's tests results will then be used to calculate reference intervals.&#xD;
&#xD;
      The study is funded by Viapath Group LLP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 13, 2021</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reference interval for transgender patients on hormone therapy</measure>
    <time_frame>1 day</time_frame>
    <description>Establish reference intervals for routine chemistry and immunoassay test for transgender people on hormone therapy. Establish separate reference intervals for people on masculinising and feminising therapy if they differ substantially.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the reference intervals in patients taking different hormone therapy formulations.</measure>
    <time_frame>1 day</time_frame>
    <description>Compare different hormone therapy formulations to establish whether there are clinically significant difference in their effects on reference intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare transgender reference intervals to the existing ones</measure>
    <time_frame>1 day</time_frame>
    <description>Compare the reference values for transgender people on hormone therapy with the existing cisgender reference intervals to establish whether they are similar enough for the cisgender reference intervals to be used instead.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Transgender Persons</condition>
  <condition>Hormone Replacement Therapy</condition>
  <condition>Reference Values</condition>
  <arm_group>
    <arm_group_label>Masculinising therapy</arm_group_label>
    <description>Healthy transgender (including non-binary) adults who are on testosterone-containing hormone therapies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Feminising therapy</arm_group_label>
    <description>Healthy transgender (including non-binary) adults who are on oestrogen-containing hormone therapies.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy transgender adults who have been taking masculinising for feminising hormone&#xD;
        therapy for at least 12 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Transgender or nonbinary people.&#xD;
&#xD;
          -  Aged 18 or older.&#xD;
&#xD;
          -  Taking testosterone or oestrogen therapy.&#xD;
&#xD;
          -  For 12 months or more.&#xD;
&#xD;
          -  Having routine hormone therapy monitoring at the clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give informed consent (including participants who cannot communicate in&#xD;
             English).&#xD;
&#xD;
          -  History of chronic liver disease, chronic kidney disease, diabetes, or severe&#xD;
             cardiovascular disease (including myocardial infection, deep vein thrombosis, stroke&#xD;
             and pulmonary embolism).&#xD;
&#xD;
          -  Blood test results that indicate severe disease.&#xD;
&#xD;
          -  Pregnant or within one year after childbirth.&#xD;
&#xD;
          -  Other conditions which could put participants at risk by participating, or which could&#xD;
             influence the results of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patients are eligible if they are transgender, that is, their gender is different from their sex assigned at birth.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Brady, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College Hospital NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Devon Buchanan, MSc</last_name>
    <email>devon.buchanan@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Brady, FRCP</last_name>
    <phone>020 3299 4535</phone>
    <email>michaelbrady@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Caldecot Centre, King's College Hospital, 15-22 Caldecot Road</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Devon Buchanan, MSc</last_name>
      <email>devon.buchanan@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Michael Brady, FRCP</last_name>
      <phone>020 3299 4535</phone>
      <email>michaelbrady@nhs.net</email>
    </contact_backup>
    <investigator>
      <last_name>Michael Brady, FRCP</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Devon Buchanan, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Tayor, FRCPath</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Royce Vincent, FRCPath</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The full protocol, deidentified participant-level data and the analysis files will be uploaded to an open access repository within 6 months of the publication of the findings.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within 6 months of the publication of the results of the research.</ipd_time_frame>
    <ipd_access_criteria>Public access to deidentified data.</ipd_access_criteria>
  </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/NCT04478760
org study id: TransRIHTS Protocol
nct id: NCT04478760
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will find out what the reference intervals are for common blood tests in
      transgender people taking hormone therapy.

      Reference intervals help doctors interpret blood test results. They are expressed as two
      numbers, and most normal results fall between them. If a results fall outside of them, it may
      be because of a disease. Some blood tests are also affected by normal difference between
      people, such as age, sex or ethnicity. For these tests, different reference intervals are
      given for each group of people. Having accurate reference intervals benefits patients because
      it allows doctors to identify disease faster.

      Transgender people have a gender identity which does not match their sex characteristics at
      birth. Gender identity is the feeling of being a gender, and sex is the biological aspects of
      growing up male or female. Transgender people may use hormone therapy to help change their
      appearance to fit their gender identity. This involves taking either oestrogen or
      testosterone.

      For blood tests which are affected by sex, it is not clear what reference intervals should be
      used for transgender people who are on hormone therapy. This is because they have a mixture
      of male and female sex characteristics. Answering this question will allow doctors to
      identify disease in them faster.

      The study will take place at cliniQ, at King's College Hospital, which provides health
      services to transgender people. It will recruit healthy transgender people who attend the
      clinic for blood tests to monitor their hormone therapy. Participants will fill out a
      questionnaire, give a urine sample, then have their appointment as normal. Extra tests will
      also be performed on their blood sample. The aim is to recruit 240 participants.
      Participant's tests results will then be used to calculate reference intervals.

      The study is funded by Viapath Group LLP.
observational model: Ecologic or Community
time perspective: Prospective
measure: Reference interval for transgender patients on hormone therapy
time frame: 1 day
description: Establish reference intervals for routine chemistry and immunoassay test for transgender people on hormone therapy. Establish separate reference intervals for people on masculinising and feminising therapy if they differ substantially.
measure: Compare the reference intervals in patients taking different hormone therapy formulations.
time frame: 1 day
description: Compare different hormone therapy formulations to establish whether there are clinically significant difference in their effects on reference intervals.
measure: Compare transgender reference intervals to the existing ones
time frame: 1 day
description: Compare the reference values for transgender people on hormone therapy with the existing cisgender reference intervals to establish whether they are similar enough for the cisgender reference intervals to be used instead.
arm group label: Masculinising therapy
description: Healthy transgender (including non-binary) adults who are on testosterone-containing hormone therapies.
arm group label: Feminising therapy
description: Healthy transgender (including non-binary) adults who are on oestrogen-containing hormone therapies.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Patients are eligible if they are transgender, that is, their gender is different from their sex assigned at birth.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Brady, FRCP
role: Principal Investigator
affiliation: King's College Hospital NHS Trust
last name: Devon Buchanan, MSc
email: devon.buchanan@nhs.net
last name: Michael Brady, FRCP
phone: 020 3299 4535
email: michaelbrady@nhs.net
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The full protocol, deidentified participant-level data and the analysis files will be uploaded to an open access repository within 6 months of the publication of the findings.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Within 6 months of the publication of the results of the research.
ipd access criteria: Public access to deidentified data.