Transgenderisme-QoL-TransNCT05761678
Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort (e-QoL-Trans)
An observational study of Transgenderism and Gender Identity, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transgenderism, Gender Identity
- What is being tested?
- Questionnaire quality of life
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2023to 21 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Transgender people, whether they have transitioned or not, with or without reassignment surgery.
Who may be able to join
- 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;
Show all 9Show fewer
- Adults;
- People able to use the tools digital;
- People with Internet or 4G access (total or limited)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital privé Jean Mermoz
Lyon, 69008
Jean-Etienne Terrier, Dr, docteur.terrier@uroclub.fr
About this study
Official title: Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort
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).
- Conditions
- Transgenderism, Gender Identity
- Being tested
- Questionnaire quality of life
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Transgender people | Whether they have transitioned or not, with or without reassignment surgery. Receives: Other: Questionnaire quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start21 Feb 2023
- Primary completion21 Aug 2025 (estimated)
- Study completion21 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761678
- Sponsor's protocol ID
- 2021-A03156-35
- Acronym
- e-QoL-Trans
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort
- ClinicalTrials.gov ID
- NCT05761678
- Acronym / sponsor ID
- e-QoL-Trans / 2021-A03156-35
- Conditions
- Transgenderism, Gender Identity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 21 Aug 2025 (estimated)
- Study completion
- 21 Feb 2026 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender people | – | Other: Questionnaire quality of lifeWhether they have transitioned or not, with or without reassignment surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Transgender people, whether they have transitioned or not, with or without reassignment surgery.
Key inclusion criteria (9 listed)
- 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:
- French-speaking people;
- Adults;
- People able to use the tools digital;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire quality of lifeQuantitative - 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. | Other | Transgender people |
Primary outcome
Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months.
Time frame: 3 months
Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgenderism and Gender Identity, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.