NCT05761678

Brief Summary

Transgender people have an identity or an expression gender that differs from the sex assigned to them at the birth. Transgender people and their needs remain misunderstood, and more generally by society. THE transgender populations express poor quality of life compared to the general population. However, very few of studies are interested in these people, in their diversity of paths, trajectories and characteristics of life. More of research is needed to study the quality of life, understand the experiences, in their diversity and in the health, social and life trajectories. Researches must be carried out, in particular on how to interrogate by the seeks out transgender people, in order to prevent stigmatization within population studies. The main objective of this study is to assess the quality of life of people transgender people during their life trajectory and their transition path, based on validated questionnaires scientifically in French, for major themes of the population concerned (quality of life, social support perceived).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 21, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2026

Completed
Last Updated

March 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

February 27, 2023

Last Update Submit

February 27, 2023

Conditions

TransgenderismGender Identity

Outcome Measures

Primary Outcomes (1)

  • Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months.

    Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months.

    3 months

Study Arms (1)

Transgender people

Whether they have transitioned or not, with or without reassignment surgery.

Other: Questionnaire quality of life

Interventions

Questionnaire quality of lifeOTHER

Quantitative - Validated online self-questionnaires scientifically to assess quality of life and support perceived social. Items created for the study concerning socio-demographic characteristics and satisfaction of health services concerning the accompaniment of the transidentity. Qualitative - Semi-structured interviews based on a guide maintenance.

Transgender people

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender people (having a gender identity or expression that differs from the sex assigned to them at birth)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Transgender people, whether they have transitioned or not, with or without reassignment surgery.

You may qualify if:

  • Transgender people (having a gender identity or expression that differs from the sex assigned to them at birth);
  • People with any of the following characteristics regarding their trans identity:
  • Consultant in one of the transgender reference centers and services for questions/information on the transition;
  • Integrated or having completed a course of care with or without gender reassignment surgery;
  • Not integrated into a health or care pathway.
  • French-speaking people;
  • Adults;
  • People able to use the tools digital;
  • People with Internet or 4G access (total or limited)

You may not qualify if:

  • People who do not identify as transgender;
  • Non-French speaking people;
  • Minors
  • People who do not know how to handle the tools digital data collection;
  • People without Internet access.
  • Non-French speaking people, unable to speak understand the research questions
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administrative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital privé Jean Mermoz

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567jf.oudet@ecten.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

February 21, 2023

Primary Completion

August 21, 2025

Study Completion

February 21, 2026

Last Updated

March 9, 2023

Record last verified: 2023-02

Locations

FR(1)