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Prospective Observational Study and Biobank CKIO

Sponsor
Odense University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04440722
Collaborator
(none)
100
Enrollment
1
Location
239
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Observational Study and Biobank in All Persons Referred to Center of Gender Identity Odense University Hospital (CKIO)/Body Identity Clinic
    Actual Study Start Date :
    Sep 1, 2020
    Anticipated Primary Completion Date :
    Aug 1, 2040
    Anticipated Study Completion Date :
    Aug 1, 2040

    Arms and Interventions

    Arm Intervention/Treatment
    Transgender individuals

    All transgender individuals referred to center of gender identity Odense

    Outcome Measures

    Primary Outcome Measures

    1. Patient reported outcomes (PRO) [Every 52 weeks]

      Questionnaires

    2. Hormone levels [Every 52 weeks]

      Blood samples

    3. Safety parameters [Every 52 weeks]

      Blood samples

    Secondary Outcome Measures

    1. Blood pressure [Every 52 weeks]

      Blood pressure measured in a sitting position

    2. Body mass index [Every 52 weeks]

      Body mass index calculated from height an weight

    3. Body weight [Every 52 weeks]

      Body weight measured on a scale in kilogram

    4. Hair cortisol [Every 52 weeks]

      Hair samples 3 mm thick from the back of the head

    5. Cortisol metabolism [Every 52 weeks]

      24 hour urine samples

    6. Spirometry [Every 52 weeks]

      Forced vital capacity is measured by a spirometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All Individuals with gender dysforia who are referred to Center of Gender Identity Odense

    • Age 18+

    Exclusion Criteria:

    °There are no exclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Endocrinology, Odense University Hospital Odense Denmark 5000

    Sponsors and Collaborators

    • Odense University Hospital

    Investigators

    • Principal Investigator: Marianne Andersen, Professor, Odense University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marianne Andersen, Consultat, Dr Med, professor, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT04440722
    Other Study ID Numbers:
    • BICTX02
    First Posted:
    Jun 22, 2020
    Last Update Posted:
    Mar 5, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 5, 2021