Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT05587751
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2022-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}, {'id': 'D010991', 'term': 'Plethysmography'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-10-19', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)', 'timeFrame': 'Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up', 'description': 'The longitudinal changes in lung volumes after both masculinizing and feminizing hormone therapy in transgender and gender diverse (TGD) patients.'}, {'measure': 'Change in forced expiratory volume', 'timeFrame': 'Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up', 'description': 'Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath'}, {'measure': 'Change in forced vital capacity', 'timeFrame': 'Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up', 'description': 'Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L)'}, {'measure': 'Change in peak expiratory flow', 'timeFrame': 'Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up', 'description': 'Measured by a peak flow meter is the maximum forced expiratory flow, reported in liter per minute (L/min)'}, {'measure': 'Change in maximal mid-expiratory flow rate', 'timeFrame': 'Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up', 'description': 'Measured by spirometry to determine the rate of airflow where half of the forced vital capacity is exhaled'}], 'secondaryOutcomes': [{'measure': 'Time of "gender adjustment" of PFT\'s normative values', 'timeFrame': 'Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up', 'description': 'The time of "gender adjustment" of PFT\'s normative values (PFTs results correlate most closely with patient\'s gender than with their sex-assigned at birth) in response to gender-affirming hormone therapy in transgender and gender diverse (TGD) patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hormonal Gender-Affirming Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects speaking any language will be offered participation.\n* Subjects capable of providing informed consent to the study. For those subjects younger than 18 years old who agree to participate in the study, informed consent will be obtained from patient's parents/guardian.\n* Subjects capable of performing pulmonary function test (PFT) maneuvers, as per pulmonary function test laboratory protocol.\n* Patients will be enrolled through the Mayo Clinic Rochester Transgender and Intersex\n* Specialty Care Clinic (TISCC), once patient has decided to undergo hormonal gender-affirming therapies (pubertal blockers, and masculinizing or feminizing hormone therapies).\n\nExclusion Criteria:\n\n* Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians.\n* The presence of contraindications for pulmonary function testing including (these will be reviewed at the time of recruitment and prior to each spirometry associated with the study):\n\n * Recent surgical procedures (\\<3 months) that could be affected by lung function testing, including the following categories: Abdominal surgery, Eye surgery, Thoracic surgery, Ear surgery, Brain surgery, Vascular surgery.\n * The presence of previously known respiratory disorders including pulmonary embolism (\\<6 months), pleural effusion, pneumothorax, hemoptysis.\n * Recent myocardial infarction (\\<1 month), new cardiac arrythmia (\\<3 months), recent cardiac pacemaker implantation (\\<3 months).\n * Heart failure symptoms, significant shortness of breath, tachycardia, or angina\n* The presence of chronic pulmonary diseases that maybe associated with changes in pulmonary function overtime such as asthma, chronic obstructive pulmonary disease, or interstitial lung diseases."}, 'identificationModule': {'nctId': 'NCT05587751', 'briefTitle': 'Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients', 'orgStudyIdInfo': {'id': '22-007173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary Function in Transgender and Gender Diverse Patients', 'description': 'Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function', 'interventionNames': ['Diagnostic Test: Spirometry', 'Diagnostic Test: Plethysmography']}], 'interventions': [{'name': 'Spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pulmonary function test to measure lung function', 'armGroupLabels': ['Pulmonary Function in Transgender and Gender Diverse Patients']}, {'name': 'Plethysmography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pulmonary function test to measure lung volume', 'armGroupLabels': ['Pulmonary Function in Transgender and Gender Diverse Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kayla L Macdonald', 'role': 'CONTACT', 'email': 'macdonald.kayla@mayo.edu', 'phone': '(507)538-0595'}], 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Kayla Quinn, MS', 'role': 'CONTACT', 'email': 'quinn.kayla2@mayo.edu', 'phone': '800-752-1606'}], 'overallOfficials': [{'name': 'Gustavo Cortes Puentes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gustavo A. Cortes Puentes', 'investigatorAffiliation': 'Mayo Clinic'}}}}