Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01922635 |
| Other study ID # |
8967 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2013 |
| Est. completion date |
January 13, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20
years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the
prognosis for survival, alter the body image imposing a "visible" deformity and of which the
treatment which aims at reducing and at stabilizing the physical deformation is binding and
expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the
everyday life of the child and on the family environment. This question is all the more
important, that all the studies show that the success of the treatment bases on the
compliance in the concentration and in the care of hygiene. The parameters of the success of
these treatments at the child are not known.
Description:
In the literature we find no specific information on the psychic and social repercussions of
the lymphœdema for the child who is affected. If the psychic and social repercussions of the
secondary lymphœdema in the breast cancer are well known, very few things are it on those of
the primary lymphœdema. Some studies estimate globally the quality of life of the patients
with a lymphœdema whatever is the origin and the etiologie. These studies of money groups
suggest that the psychic difficulties and of therapeutic care are not identical. A single
study approaches the specific question of the lymphœdema of the child by focusing on the
real-life experience of expanding child of a primary lymphœdema.The construction and the
validation of a tool measuring the quality of life of the children and the young adults
affected by lymphœdema congenital appears as a starting point. A tool which would first of
all allow to make the current situation for the regional level, and then can envisage
national actions common. According to recent studies, the evolution of the lymphoedema is
different according to the forms of initial clinical expression of the lymphoedema, we wish
we can thus know during this study the impact of these various clinical forms on the quality
of life of the patients. A genetic collection will be realized for that purpose (genetic
research).
