- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195659
Chest Dysphoria in Transmasculine Spectrum Adolescents
June 8, 2022 updated by: Sumanas Jordan, Northwestern University
The Effect of Top Surgery on Chest Dysphoria in Assigned-Female-At-Birth, Transmasculine Spectrum Youth and Young Adults
The investigators hypothesize that masculinizing top surgery (e.g., mastectomy and chest masculinization) leads to an improvement in self-report chest dysphoria, gender dysphoria, and gender congruence in assigned-female-at-birth, transgender and non-binary youth and young adults.
This is a prospective, observational study that will enroll assigned-female-at-birth, transmasculine spectrum individuals age 13 to 25 years old who are or are not undergoing top surgery.
Participants will complete a set of standard of care questionnaires regarding their chest dysphoria (e.g., distress about the chest), gender dysphoria (e.g., distress about a gender identity that does not match assigned sex), and gender congruence (e.g., degree to which an individual feels they are living in their authentic appearance and gender identity).
They will complete this same set of questionnaires either three months after their top surgery or three months after the initial set of surveys.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
81
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Chicago, Illinois, United States, 60611
- Ann and Robert H Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States, 60612
- University of Illinois Chicago
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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.
Eligibility Criteria
Ages Eligible for Study
9 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Top surgery participants will be recruited from plastic surgery practices at Northwestern University, the Ann and Robert H Lurie Children's Hospital of Chicago, and the University of Illinois Chicago.
Matched controls will be recruited from the Lurie Children's Hospital Gender and Sex Development Program.
Description
Inclusion Criteria:
- Assigned the female sex at birth
- Affirmed gender identity of male, non-binary, or gender other than female
- English-speaking
- Undergoing top surgery or matches a top surgery participant on age and number of months on testosterone
Exclusion Criteria:
- Non English speaking
- Unable to complete self-report questionnaires
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Top Surgery
Individuals assigned the female sex at birth, who identify as a gender other than female, are between the ages of 13 and 25 years, and who are undergoing mastectomy and chest masculinization in one of three plastic surgery practices in Chicago.
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A surgical procedure in which the breasts are removed and the chest is given a masculine contour.
|
|
Control
Individuals assigned the female sex at birth, who identify as a gender other than female, are between the ages of 13 and 25 years, were seen in a gender development clinic in Chicago, and who are not planning to undergo top surgery.
Controls will be matched with top surgery patients on age and number of months of testosterone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest Dysphoria
Time Frame: Three month
|
The disruption of individual comfort, physical functioning, and interpersonal relationships from a chest with breasts, as measured by the Chest Dysphoria Measure (Score 0-51, Higher number means greater chest dysphoria)
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Three month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gender Dysphoria
Time Frame: Three month
|
Distress about a gender identity that differs from assigned sex, measured by the Utrecht Gender Dysphoria Scale (Score 12-60, Higher number means greater gender dysphoria)
|
Three month
|
|
Gender Congruence
Time Frame: Three month
|
Feelings of living in an authentic gender identity and appearance, as measured by the Kozee Transgender Congruence Scale (Score 12-60, Higher number means greater gender congruence)
|
Three month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sumanas W Jordan, MD PhD, Northwestern University
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 Major Dates
Study Start (Actual)
October 29, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
December 10, 2019
First Submitted That Met QC Criteria
December 11, 2019
First Posted (Actual)
December 12, 2019
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP0052757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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