Clinical trial NCT04478760: Trans & Non-binary Reference Intervals While on Hormone Therapy Study
Official title: Reference Intervals for 27 Routine Chemistry and Immunoassay Tests in Transgender Adults on Stable Hormone Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgender Persons
Hormone Replacement Therapy
Reference Values
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy transgender adults who have been taking masculinising for feminising hormone therapy for at least 12 months.

Brief 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 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 Criteria:

* Unable to give informed consent (including participants who cannot communicate in English).
* History of chronic liver disease, chronic kidney disease, diabetes, or severe cardiovascular disease (including myocardial infection, deep vein thrombosis, stroke and 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 could influence the results of the study.

Primary outcomes:
measure: Reference interval for transgender patients on hormone therapy
timeFrame: 1 day
Secondary outcomes:
measure: Compare the reference intervals in patients taking different hormone therapy formulations.
timeFrame: 1 day
measure: Compare transgender reference intervals to the existing ones
timeFrame: 1 day
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Caldecot Centre, King's College Hospital, 15-22 Caldecot Road
Study officials:
affiliation: King's College Hospital NHS Trust
name: Michael Brady, FRCP
role: PRINCIPAL_INVESTIGATOR
References: