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Validation Lymphoqol (0)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
University Hospital, Marseille
Information provided by (Responsible Party):
University Hospital, Montpellier Identifier:
First received: August 12, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
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.

Condition Intervention
Primary Lymhedema
Other: Valadation of the metrological properties of questionnaire of quality of life

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Validation of Metrological Properties of Questionnaire of Quality of Life LYMPHOQOL

Resource links provided by NLM:

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Validation of the metrological properties of questionnaire of quality of life LYMPHOQOL [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Other: Valadation of the metrological properties of questionnaire of quality of life

Detailed 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).

Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary lymphedema, stage 2 or 3 ISL

Exclusion Criteria:

  • Primary lymphedema stage 1, secondary lymphedema, Minimum 6 years, maximum 25
  Contacts and Locations
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Please refer to this study by its identifier: NCT01922635

CHU Montpellier
Montpellier, Herault, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Marseille
  More Information

Responsible Party: University Hospital, Montpellier Identifier: NCT01922635     History of Changes
Other Study ID Numbers: UF 8967 
Study First Received: August 12, 2013
Last Updated: August 12, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Montpellier:
Primary lymphedema quality of life, genetic research processed this record on December 09, 2016