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

Reference Intervals for 27 Routine Chemistry and Immunoassay Tests in Transgender Adults on Stable Hormone Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Hormone Replacement Therapy; Transgender Persons; Reference Values

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Devon Buchanan, MSc; Email: devon.buchanan@nhs.net
• Study Contact Backup: Name: Michael Brady, FRCP; Phone Number: 020 3299 4535; Email: michaelbrady@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • Caldecot Centre, King's College Hospital, 15-22 Caldecot Road
    • Contact: Devon Buchanan, MSc; Email: devon.buchanan@nhs.net
    • Contact: Michael Brady, FRCP; Phone Number: 020 3299 4535; Email: michaelbrady@nhs.net
    • Principal Investigator: Michael Brady, FRCP
    • Sub-Investigator: Devon Buchanan, MSc
    • Sub-Investigator: David Tayor, FRCPath
    • Sub-Investigator: Royce Vincent, FRCPath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy transgender adults who have been taking masculinising for feminising hormone therapy for at least 12 months.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Masculinising therapy; Healthy transgender (including non-binary) adults who are on testosterone-containing hormone therapies.
Feminising therapy; Healthy transgender (including non-binary) adults who are on oestrogen-containing hormone therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reference interval for transgender patients on hormone therapy	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the reference intervals in patients taking different hormone therapy formulations.	Compare different hormone therapy formulations to establish whether there are clinically significant difference in their effects on reference intervals.	1 day
Compare transgender reference intervals to the existing ones	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.	1 day

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Michael Brady, FRCP, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TransRIHTS Protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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 Sharing Time Frame: Within 6 months of the publication of the results of the research.
• IPD Sharing Access Criteria: Public access to deidentified data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No