Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People. (TRANS'ITION)

May 19, 2026 updated by: University Hospital, Lille

Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.

Transgender people can benefit from psychological, psychiatric, endocrinological support, sexual reassignment surgery, sexology support and dermatological care. The value of transitional care courses is scientifically recognized. Currently, the modalities of decision and realization of the care paths are heterogeneous on the territory, little standardized, and are the subject of debates between representatives of users and medical teams.

The french national report of IGAS from 2011 warns of the need to argue and legitimize care practices through more numerous, more exhaustive scientific studies, presenting a better level of evidence

Since 2011, no prospective study has been carried out on the national and international level, making it possible to assess the relevance of the planned care modalities. This research project, conducted over five consecutive years at the first contact of a transgender people with a care device, aims to correlate a variation in the quality of life of people with the characteristics of the care methods provided. This is a first proposal to assess care practices for transgender people. The results of this study would first allow us to infer the care modalities most suited to the needs of people. Secondly, secondary hypotheses could support new experimental protocols.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This research is a prospective multicenter cohort study with a 3-year and 5-year follow-up of transgender people in medical transition.

Main aim:

Evaluate the evolution of the quality of life during five years in transgender people who benefit from transition support cares.

Secondary objectives:

Secondary objective n°1 :

Identify the different factors that influence the evolution of quality of life evaluated over three years in transgender people who benefit from transition support cares.

Secondary objective n°2 :

Evaluate the evolution of the satisfaction of the shared medical decision for transgender people in medical transition.

Secondary objective n°3 :

Evaluate the evolution of the satisfaction of body image for transgender people in medical transition.

Secondary objective n°4 :

Evaluate the evolution of psychiatric comorbidities for transgender people in medical transition.

Secondary objective n°5 :

Evaluate the benefits and limits in long term (five years) on the quality of life, the satisfaction of the shared medical decision, the satisfaction of body image and the evolution of psychiatric comorbidities.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux
        • Contact:
          • Romain WEIGERT
      • Brest, France
        • CHU de Brest
        • Contact:
          • Véronique KERLAN
      • Béziers, France
        • Centre Hospitalier de Beziers
        • Contact:
          • Cyril IMBERT
      • Caen, France
        • CHU De Caen
        • Contact:
          • Yves REZNIK
        • Sub-Investigator:
          • Bleuenn DREVES
      • Lille, France
        • CHU de Lille
        • Contact:
          • Francois MEDJKANE
        • Contact:
          • Anne-Laure DEMARTY
      • Lille, France
        • Maison de Santé Lille Moulins
        • Contact:
          • Nassir MESSAADI
      • Lille, France
        • Maison de Santé Lille Sud
        • Sub-Investigator:
          • Gwendoline EECKHOUT
        • Sub-Investigator:
          • Guillaume BRUNELIERE
        • Contact:
          • Sophie DUPONT
      • Lyon, France
        • CHU de Lyon
        • Contact:
          • Ludovic SOUILLER
        • Contact:
          • Lucie JUREK
      • Lyon, France
        • G..R.E.T.T.I.S
        • Contact:
          • Nicolas MOREL-JOURNEL
      • Marseille, France
        • Hôpital de la Conception - Marseille
        • Contact:
          • Delphine DRAI
      • Nice, France
        • CHU de NICE
        • Contact:
          • Michel BENOIT
      • Paris, France
        • Centre Hospitalier Sainte-Anne
        • Contact:
          • Thierry GALLARDA
      • Paris, France
        • Centre Hospitalier Maison Blanche
        • Contact:
          • Jean CHAMBRY

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

transgender people in medical transition

Description

Inclusion Criteria:

  • With a diagnosis of Gender Dysphoria according to DSM5 diagnostic criteria
  • Wishing to benefit from supportive care for their transition trajectory and addressing a care system represented by the collaborating centers participating in the study,
  • Willing to comply with all study procedures and duration,
  • Understanding and able to speak French.

Exclusion Criteria:

  • Minor or adult under curatorship, under judicial protection, persons deprived of their liberty
  • Refusal to participate after clear and fair information from the study
  • Person with sexual reassignment surgery or with cross hormon therapy since two years.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life scores
Time Frame: 3 years
Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social factors (age, gender, profession, knowledge of care system)
Time Frame: Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Answers given by the patient during interview
Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Satisfaction of the shared medical decision
Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Scores on the CDIS (Clinical Decision-making Involvement and Satisfaction) clinical decision making involvement and satisfaction score 15 questions scored 1-5 (totally disagree, strongly disagree, neither agree nor disagree, strongly agree, totally agree)
6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Satisfaction of body image
Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Score on the BIS (Body Image Scale), total score ranges from 0 to 30, A higher score means a higher level of body image disturbance
6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
General psychopathology
Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
French version of Mini International Neuropsychiatric Interview (DSM)
6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Anxiety and depression
Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Anxiety and depression scores on the HAD scale (Hospital Anxiety and Depression scale), a score upper 8 means is considered as a risk of an anxiety or depressive disorder
6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Quality of life scores
Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 5 years
Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale
6 months, 12 months, 18 months, 24 months, 30 months, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: François MEDJKANE, MD, University Hospital, Lille

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 (Estimated)

January 1, 2027

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

December 24, 2021

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_09
  • 2021-A00154-37 (Other Identifier: ID-RCB number, ANSM)
  • PREPS-19-0078 (Other Identifier: AAP number, DGOS)

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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