Trans & Non-binary Reference Intervals While on Hormone Therapy Study

Last updated: March 6, 2024
Sponsor: King's College Hospital NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hormone Replacement Therapy

Treatment

N/A

Clinical Study ID

NCT04478760
TransRIHTS Protocol
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Transgender or nonbinary people.
  • Aged 18 or older.
  • Taking testosterone or oestrogen therapy.
  • For 12 months or more.
  • Having routine hormone therapy monitoring at the clinic.

Exclusion

Exclusion Criteria:

  • Unable to give informed consent (including participants who cannot communicate inEnglish).
  • History of chronic liver disease, chronic kidney disease, diabetes, or severecardiovascular disease (including myocardial infection, deep vein thrombosis, strokeand pulmonary embolism).
  • Blood test results that indicate severe disease.
  • Pregnant or within one year after childbirth.
  • Other conditions which could put participants at risk by participating, or which couldinfluence the results of the study.

Study Design

Total Participants: 240
Study Start date:
April 13, 2021
Estimated Completion Date:
April 30, 2024

Connect with a study center

  • Caldecot Centre, King's College Hospital, 15-22 Caldecot Road

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

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