Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.
NCT ID: NCT05273112
Last Updated: 2023-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
400 participants
OBSERVATIONAL
2023-04-30
2030-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion 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
* Refusal to participate after clear and fair information from the study
* Person with sexual reassignment surgery or with cross hormon therapy since two years.
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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François MEDJKANE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Centre Hospitalier de Béziers
Béziers, , France
CHU de Bordeaux
Bordeaux, , France
CHU de Brest
Brest, , France
CHU de Caen
Caen, , France
CHU de Lille
Lille, , France
Maison de Santé Lille Moulins
Lille, , France
Maison de Santé Lille Sud
Lille, , France
CHU de Lyon
Lyon, , France
G..R.E.T.T.I.S
Lyon, , France
Hopital de la Conception - Marseille
Marseille, , France
CHU de Nice
Nice, , France
Centre Hospitalier Maison Blanche
Paris, , France
Centre Hospitalier Sainte-Anne
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Cyril IMBERT
Role: primary
Romain WEIGERT
Role: primary
Véronique KERLAN
Role: primary
Yves REZNIK
Role: primary
Francois MEDJKANE
Role: primary
Anne-Laure DEMARTY
Role: backup
Nassir MESSAADI
Role: primary
Sophie DUPONT
Role: primary
Ludovic SOUILLER
Role: primary
Lucie JUREK
Role: backup
Nicolas MOREL-JOURNEL
Role: primary
Delphine DRAI
Role: primary
Michel BENOIT
Role: primary
Jean CHAMBRY
Role: primary
Thierry GALLARDA
Role: primary
Other Identifiers
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2021-A00154-37
Identifier Type: OTHER
Identifier Source: secondary_id
PREPS-19-0078
Identifier Type: OTHER
Identifier Source: secondary_id
2020_09
Identifier Type: -
Identifier Source: org_study_id
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