NCT06854965

Brief Summary

This research focuses on identifying medical, social, and healthcare journey determinants associated with the evolution of quality of life in the transgender population at 12 months. To address the research question, it is planned to include 1,500 transgender individuals, among those attending healthcare professionals or associations in the French territory who have agreed to take on the role of investigators (professionals in healthcare or designated individuals within an association).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress59%
Feb 2025Feb 2027

First Submitted

Initial submission to the registry

February 3, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

February 3, 2025

Last Update Submit

February 28, 2025

Conditions

Keywords

TransgenderQuality of Life (QoL)

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life (WHOQOL-BREF) between 0 and 12 months.

    Differences in the WHOQOL-BREF between 0 and 12 months. The WHOQOL-BREF (World Health Organization Quality Of Life tool) consists of four dimensions: physical health, psychological health, social relationships and environment, with scores ranging from 0 to 100. A higher score denotes a higher quality of life.

    From enrollment to the last questionnaire at 12 months

Secondary Outcomes (12)

  • Quality of life (WHOQOL-BREF) at baseline and 6 months

    Baseline and 6 months

  • Change in quality of life (WHOQOL-BREF) between 0 and 6 months.

    From baseline to 6 months

  • Mental health at baseline

    Baseline

  • Sexual health at baseline

    Baseline

  • Addictions at baseline

    Baseline

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender Individuals
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Transgender Individuals

You may qualify if:

  • Person identifying themselves as trans
  • Person of legal age (≥ 18 years)
  • Person living in France
  • Person who has not expressed any opposition after receiving full information about the protocol
  • Person who understands and speaks French, or who is an allophone speaking English, Spanish or Portuguese

You may not qualify if:

  • People who do not understand or speak French, English, Spanish or Portuguese.
  • Person under guardianship or curatorship, under legal protection or under safeguard of justice
  • Anyone who has expressed their opposition after receiving full information about the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNGE Conseil

Paris, 75011, France

Location

Central Study Contacts

El Mountacer Billah EL ABBASSI, Ph.D

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 3, 2025

First Posted

March 3, 2025

Study Start

February 28, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations