Gender Affirming Hormone Therapy and Immune Function in Trans Individuals - The GIFT Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transgender. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Our immune systems protect us from infection but can also cause disease, for example by attacking our own bodies (autoimmune disease), or driving chronic inflammation in conditions such as heart disease. The immune systems of men and women function differently, as evidenced by differing rates of disease with autoimmune disease being more common in women whilst men are more susceptible to infection. We don't know why these differences exist, but if we could understand we may be able to develop new treatments to treat or prevent immune driven diseases. So far, we know that both sex chromosomes and hormones affect how the immune system functions, but not the exact contribution of each or how they interact. One way to study this is to work with transgender people. Transgender people identify as a gender different from their sex assigned at birth and some may choose to take the sex hormones of the gender they identify with, which is known as gender affirming hormone therapy (GAHT). Given that these changes affect their sex hormone profile and not their chromosomes, any changes in their immune system would be driven by hormones only. This would help us understand not only how sex hormones shape the immune system more generally, but also the disease risk in transgender people and enable better patient counselling. In this study, transgender patients starting on GAHT at 56 Dean Street clinic in London would be invited to donate blood samples before starting therapy, at 1 month (optional) and at 3 and 6 months. These samples would be analysed at the Laboratory of Medical Sciences to examine how the different types of immune cells change with therapy and how they respond to different immune triggers (stimuli). We aim to recruit 500 individuals and anticipate the study will last up to 3 years.
Primary outcome measures
- Immune system adaptations to gender affirming hormone therapy [Time frame: 3 years]
Secondary outcome measures (2)
- Hormone concentrations [Time frame: 3 years]
- Immune-related blood protein levels [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Adults between 18 and 50 years of age with diagnosed gender dysphoria about to start gender-affirming hormone therapy with either oestrogen or testosterone.
Exclusion criteria
- Lack of capacity to consent.
- Abnormalities in expected pubertal development and pharmacological interventions that could affect levels of gonadal steroids including suspected or confirmed self-treatment with steroid hormone preparations in preceding month (birth control excluded).
- Serious immunological disease (immune deficiency, autoimmune disease requiring immunomodulatory treatment).
- Regular immunomodulatory treatment such as prednisolone or biological drugs.
- In the case of vaccination or symptomatic infection ≤5 days before the visit blood sampling should be postponed by 1 week.
- Age <18 years or >50 years
- Completed menopause (persons assigned female sex at birth).
- Positivity for blood borne viruses (HIV, Hepatitis B, Hepatitis C, HTLV-1)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07358897 · 182929 · 361618