Gender DysphoriaDyGenEpiNCT04573127
Gender Dysphoria: Epidemiological Data
An observational study of Gender Dysphoria, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in CHRU de Nancy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- descriptive study
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2020to Nov 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the outpatient clinic at our department of endocrinology
Retrospective analysis of available data as a part of the regular care of subjects with gender dysphoria. All measurements were made at the time of the routine follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Characteristics of the Population of Persons With Gender Dysphoria : Data From the Cohort Follow-up in CHRU de Nancy
Retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in CHRU de Nancy
- Conditions
- Gender Dysphoria
- Being tested
- descriptive study
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptive studyOther
Also called Retrospective analysis of existing data collected as a part of the regular follow-up
Retrospective analysis of existing data collected as a part of the regular follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
Incdience rate of cardiovascular diseases
Number of new cases of arterial hypertension, stroke, myocardial infarction during the specified period (2004-2020) /Time each person was observed, totaled for all persons
Measured: 2004-2020
Incidence rate of dyslipidemia
Number of new cases of dyslipidemia during the specified period (2004-2020) /Time each person was observed, totaled for all persons
Measured: 2004-2020
Secondary outcomes (3)
Incidence rate of oncological diseases
Number of new cases of malignancies during the specified period (2004-2020) /Time each person was observed, totaled for all persons
Measured: 2004-2020
Incidence rate of psychiatric diseases
Number of new cases of psychiatric diseases malignancies during the specified period (2004-2020) /Time each person was observed, totaled for all persons
Measured: 2004-2020
Overall mortality rate
Mortality during the specified period (2004-2020) /Time each person was observed, totaled for all persons
Measured: 2004-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start27 Jul 2020
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573127
- Sponsor's protocol ID
- 2020PI159
- Acronym
- DyGenEpi
- Status last verified
- Jul 2020
- First submitted
- 7 Aug 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Characteristics of the Population of Persons With Gender Dysphoria : Data From the Cohort Follow-up in CHRU de Nancy
- ClinicalTrials.gov ID
- NCT04573127
- Acronym / sponsor ID
- DyGenEpi / 2020PI159
- Conditions
- Gender Dysphoria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 5 Oct 2020 (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.
Retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in CHRU de Nancy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the outpatient clinic at our department of endocrinology
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 |
|---|---|---|
| descriptive studyAlso: Retrospective analysis of existing data collected as a part of the regular follow-upRetrospective analysis of existing data collected as a part of the regular follow-up | Other | – |
Primary outcome
Incdience rate of cardiovascular diseases
Time frame: 2004-2020
Number of new cases of arterial hypertension, stroke, myocardial infarction during the specified period (2004-2020) /Time each person was observed, totaled for all persons
Incidence rate of dyslipidemia
Time frame: 2004-2020
Number of new cases of dyslipidemia during the specified period (2004-2020) /Time each person was observed, totaled for all persons
3 secondary outcomes
Incidence rate of oncological diseases
Time frame: 2004-2020
Incidence rate of psychiatric diseases
Time frame: 2004-2020
Overall mortality rate
Time frame: 2004-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: Undecided
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GLOW: Gender-Affirming Care and Mental Health: A Longitudinal Study On Quality of Life, Work Life, and Healthcare Outcomes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gender Dysphoria, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incdience rate of cardiovascular diseases (time frame: 2004-2020). The study lists 2 primary outcomes in all. 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 5 Oct 2020.