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Not yet recruitingNCT05273112TRANS'ITIONUpdated May 20, 2026

Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.

An observational study in Gender Dysphoria, sponsored by University Hospital, Lille. Not yet recruiting at 13 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Gender Dysphoria with a site in France — 3 open to participants now, 3 under way, 1 of them phase 3. Gender Dysphoria · France.

Planned enrollment
Largest of 10
400 · median 110
Started
2027
the only one that year
Observational
10 of 11
2 open now
Registered
9th of 11
by date
Lead sponsor
1 of 11
University Hospital, Lille

Among the 11 studies in Gender Dysphoria with a site in France, this one has the largest planned enrollment of the 10 observational ones that give a count, is the only one that started in 2027, is one of 10 observational ones, and was the 9th registered.

Gender Dysphoria

85 studies on the registry are indexed under Gender Dysphoria; 38 are open to participants now.

This study's planned enrollment of 400 is above the median of 100 across 52 observational studies indexed under Gender Dysphoria.

Browse Gender Dysphoria studies →

Open to participants now

3 of the 11 studies in Gender Dysphoria with a site in France are open now, in 1 country. Each count lists the studies.

All 3 open studies →

Where they have run

Who these studies take

Of the 31 Gender Dysphoria studies recruiting now, 15 (48%) set no upper age limit and 10 (32%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Gender Dysphoria with a site in France, or all of them as a file.
02

Study summary

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.

Read the 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.

03

Conditions studied

  • Gender Dysphoria

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Keywords

  • Transidentity
  • Gender Dysphoria
  • Transition
  • Quality of Life
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

transgender people in medical transition

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Quality of life scores

    Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale

    Time frame: 3 years

Secondary outcomes

  1. Social factors (age, gender, profession, knowledge of care system)

    Answers given by the patient during interview

    Time frame: Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  2. Satisfaction of the shared medical decision

    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)

    Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  3. Satisfaction of body image

    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

    Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  4. General psychopathology

    French version of Mini International Neuropsychiatric Interview (DSM)

    Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  5. Anxiety and depression

    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

    Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  6. Quality of life scores

    Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale

    Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 5 years

07

Study locations

13 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Apr 2030, 39 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2021
First posted
Mar 10, 2022
StartEst.
Jan 2027
Primary completionEst.
Apr 2030
CompletionEst.
Apr 2030
Last update
May 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05273112
Responsible party
Sponsor
First posted
Mar 10, 2022
Start date
Jan 2027 (estimated)
Primary completion
Apr 2030 (estimated)
Completion
Apr 2030 (estimated)
Last update
May 20, 2026

Study contacts

François MEDJKANE, MD
Contact
francois.medjkane@chru-lille.fr
0320445962 ext. +33
François MEDJKANE, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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