- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573127
Gender Dysphoria: Epidemiological Data (DyGenEpi)
September 28, 2020 updated by: Central Hospital, Nancy, France
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
Study Overview
Study Type
Observational
Enrollment (Anticipated)
320
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nancy, France, 54000
- CHRU Nancy
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
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
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2004-2020
|
|
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
|
2004-2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence rate of oncological diseases
Time Frame: 2004-2020
|
Number of new cases of malignancies during the specified period (2004-2020) /Time each person was observed, totaled for all persons
|
2004-2020
|
|
Incidence rate of psychiatric diseases
Time Frame: 2004-2020
|
Number of new cases of psychiatric diseases malignancies during the specified period (2004-2020) /Time each person was observed, totaled for all persons
|
2004-2020
|
|
Overall mortality rate
Time Frame: 2004-2020
|
Mortality during the specified period (2004-2020) /Time each person was observed, totaled for all persons
|
2004-2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
July 27, 2020
Primary Completion (Anticipated)
November 1, 2021
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
August 7, 2020
First Submitted That Met QC Criteria
September 28, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
September 28, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.