RECRUITING

Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse Patients

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Conditions

Hormonal Gender-Affirming Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.

Official Title

Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients

Quick Facts

Study Start:2023-02-01
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05587751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects speaking any language will be offered participation.
  2. * 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.
  3. * Subjects capable of performing pulmonary function test (PFT) maneuvers, as per pulmonary function test laboratory protocol.
  4. * Patients will be enrolled through the Mayo Clinic Rochester Transgender and Intersex
  5. * Specialty Care Clinic (TISCC), once patient has decided to undergo hormonal gender-affirming therapies (pubertal blockers, and masculinizing or feminizing hormone therapies).
  1. * Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians.
  2. * 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):
  3. * 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.
  4. * The presence of previously known respiratory disorders including pulmonary embolism (\<6 months), pleural effusion, pneumothorax, hemoptysis.
  5. * Recent myocardial infarction (\<1 month), new cardiac arrythmia (\<3 months), recent cardiac pacemaker implantation (\<3 months).
  6. * Heart failure symptoms, significant shortness of breath, tachycardia, or angina
  7. * 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.

Contacts and Locations

Study Contact

Kayla MacDonald, MS
CONTACT
800-752-1606
macdonald.kayla@mayo.edu

Principal Investigator

Gustavo Cortes Puentes, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Gustavo Cortes Puentes, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2025-07

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

  • Hormonal Gender-Affirming Therapy