Informations générales (source: ClinicalTrials.gov)
Development and Validation of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations Aged 11 to 15 Years-old. (MVFL)
Interventional
N/A
University Hospital, Toulouse (Voir sur ClinicalTrials)
février 2018
février 2019
29 juin 2024
The low-flow malformations include venous and lymphatic malformations. The malformation
often affects the skin and can extend deep to the muscles and bone, as well as to deep
organs. Children with low-flow vascular malformation and their family have difficulty
living with their illness and have an impact on their life quality.
In this context, the aim of the study is to develope life quality test for the children
between 11 to 15 years old.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| UHBordeaux - 33076 - Bordeaux - France | Christine Leauté-Labrèze, MD | Contact (sur clinicalTrials) | |||
| UHChambray - 37170 - Chambray-lès-Tours - France | Annabel Maruani-Raphael, MD | Contact (sur clinicalTrials) | |||
| UHNantes - 44093 - Nantes - France | Sébastien Barbarot, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Phase 1:
- Patient with slow-flow vascular malformation, regardless of clinical form, severity
(clinical and imaging diagnosis), aged 11 to 15 years-old.
- Patient with slow-flow vascular malformation, whatever its clinical form, its
severity (clinical and imaging diagnosis), aged over 15 years-old.
- Parents of a patient with slow-flow vascular malformation, regardless of clinical
form, severity (clinical and imaging diagnosis), aged 11 to 15 years-old inclusive
- Patient affiliated to a social security scheme
- Patient having given his consent or for the minor whose legal representative has
given written informed consent.
Phase 2 :
- Patient with slow-flow vascular malformation, regardless of clinical form, severity
(clinical and imaging diagnosis), 11 to 15 years-old of age included.
- Patient affiliated to a social security scheme
- Patient having given his consent or for the minor whose legal representative has
given his informed consent
Exclusion criteria :
For both phases: Pregnant or lactating women or girls,
- Vulnerable persons,
- Majors subject to a legal protection measure or unable to express their consent
Phase 1: Patient or parent who does not speak the French language and therefore are
unable to express themselves in the focus groups.
- Patient under 11 years-old; Phase 2 : Patient who does not speak French and is
therefore unable to complete quality of life questionnaires
- Patient under 11 or over 15 years-old.
Phase 1:
- Patient with slow-flow vascular malformation, regardless of clinical form, severity
(clinical and imaging diagnosis), aged 11 to 15 years-old.
- Patient with slow-flow vascular malformation, whatever its clinical form, its
severity (clinical and imaging diagnosis), aged over 15 years-old.
- Parents of a patient with slow-flow vascular malformation, regardless of clinical
form, severity (clinical and imaging diagnosis), aged 11 to 15 years-old inclusive
- Patient affiliated to a social security scheme
- Patient having given his consent or for the minor whose legal representative has
given written informed consent.
Phase 2 :
- Patient with slow-flow vascular malformation, regardless of clinical form, severity
(clinical and imaging diagnosis), 11 to 15 years-old of age included.
- Patient affiliated to a social security scheme
- Patient having given his consent or for the minor whose legal representative has
given his informed consent
Exclusion criteria :
For both phases: Pregnant or lactating women or girls,
- Vulnerable persons,
- Majors subject to a legal protection measure or unable to express their consent
Phase 1: Patient or parent who does not speak the French language and therefore are
unable to express themselves in the focus groups.
- Patient under 11 years-old; Phase 2 : Patient who does not speak French and is
therefore unable to complete quality of life questionnaires
- Patient under 11 or over 15 years-old.