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New study aims to improve blood test accuracy for transgender patients

NCT ID NCT04478760

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study will determine the normal reference intervals for 27 common blood tests in transgender adults who have been on stable hormone therapy for at least a year. Currently, standard reference ranges are based on sex assigned at birth, which may not be accurate for transgender individuals. By recruiting 250 healthy transgender participants, researchers hope to provide doctors with better tools to interpret lab results and detect disease earlier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide doctors with accurate reference ranges for common blood tests in transgender people on hormone therapy, leading to faster and more accurate disease detection.
What could go wrong
This is an observational study, not a treatment trial. It only establishes reference intervals and does not test any new therapy. Results may not apply to all transgender individuals or those on different hormone regimens.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

250 people

The number who actually took part.

Started

Apr 2021

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    London, SE5 9RS, United Kingdom

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