Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT04478760
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans & Non-binary Reference Intervals While on Hormone Therapy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reference interval for transgender patients on hormone therapy', 'timeFrame': '1 day', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Compare the reference intervals in patients taking different hormone therapy formulations.', 'timeFrame': '1 day', 'description': 'Compare different hormone therapy formulations to establish whether there are clinically significant difference in their effects on reference intervals.'}, {'measure': 'Compare transgender reference intervals to the existing ones', 'timeFrame': '1 day', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgender Persons', 'Hormone Replacement Therapy', 'Reference Values']}, 'descriptionModule': {'briefSummary': "This study will find out what the reference intervals are for common blood tests in transgender people taking hormone therapy.\n\nReference 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.\n\nTransgender 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.\n\nFor 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.\n\nThe 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.\n\nThe study is funded by Viapath Group LLP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy transgender adults who have been taking masculinising for feminising hormone therapy for at least 12 months.', 'genderDescription': 'Patients are eligible if they are transgender, that is, their gender is different from their sex assigned at birth.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transgender or nonbinary people.\n* Aged 18 or older.\n* Taking testosterone or oestrogen therapy.\n* For 12 months or more.\n* Having routine hormone therapy monitoring at the clinic.\n\nExclusion Criteria:\n\n* Unable to give informed consent (including participants who cannot communicate in English).\n* History of chronic liver disease, chronic kidney disease, diabetes, or severe cardiovascular disease (including myocardial infection, deep vein thrombosis, stroke and pulmonary embolism).\n* Blood test results that indicate severe disease.\n* Pregnant or within one year after childbirth.\n* Other conditions which could put participants at risk by participating, or which could influence the results of the study.'}, 'identificationModule': {'nctId': 'NCT04478760', 'acronym': 'TransRIHTS', 'briefTitle': 'Trans & Non-binary Reference Intervals While on Hormone Therapy Study', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'Reference Intervals for 27 Routine Chemistry and Immunoassay Tests in Transgender Adults on Stable Hormone Therapy', 'orgStudyIdInfo': {'id': 'TransRIHTS Protocol'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Masculinising therapy', 'description': 'Healthy transgender (including non-binary) adults who are on testosterone-containing hormone therapies.'}, {'label': 'Feminising therapy', 'description': 'Healthy transgender (including non-binary) adults who are on oestrogen-containing hormone therapies.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "Caldecot Centre, King's College Hospital, 15-22 Caldecot Road", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Michael Brady, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Within 6 months of the publication of the results of the research.', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'Public access to deidentified data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}