NCT04195659

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

2.2 years

First QC Date

December 10, 2019

Last Update Submit

June 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chest Dysphoria

    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)

    Three month

Secondary Outcomes (2)

  • Gender Dysphoria

    Three month

  • Gender Congruence

    Three month

Study Arms (2)

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.

Procedure: Mastectomy and chest masculinization

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.

Interventions

A surgical procedure in which the breasts are removed and the chest is given a masculine contour.

Top Surgery

Eligibility Criteria

Age13 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must identify as a gender other than female
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Non English speaking
  • Unable to complete self-report questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ann and Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Gender Dysphoria

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Sumanas W Jordan, MD PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 12, 2019

Study Start

October 29, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 10, 2022

Record last verified: 2022-06

Locations