NCT04573127

Brief Summary

Retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in CHRU de Nancy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

October 5, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

August 7, 2020

Last Update Submit

September 28, 2020

Conditions

Gender Dysphoria

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    2004-2020

Secondary Outcomes (3)

  • Incidence rate of oncological diseases

    2004-2020

  • Incidence rate of psychiatric diseases

    2004-2020

  • Overall mortality rate

    2004-2020

Interventions

descriptive studyOTHER

Retrospective analysis of existing data collected as a part of the regular follow-up

Also known as: Retrospective analysis of existing data collected as a part of the regular follow-up

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsSubjects 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
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2020

First Posted

October 5, 2020

Study Start

July 27, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

October 5, 2020

Record last verified: 2020-07

Locations

FR(1)