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Validation of Metrological Properties of Lymphoqol (LYMPHOQOL)

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ClinicalTrials.gov Identifier: NCT01922635
Recruitment Status : Unknown
Verified December 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : August 14, 2013
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
University Hospital, Marseille
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Lymhedema Other: Valadation of the metrological properties of questionnaire of quality of life Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Validation of Metrological Properties of Questionnaire of Quality of Life LYMPHOQOL
Study Start Date : July 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
1 Other: Valadation of the metrological properties of questionnaire of quality of life



Primary Outcome Measures :
  1. Validation of the metrological properties of questionnaire of quality of life LYMPHOQOL [ Time Frame: 3 Years ]


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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary lymphedema, stage 2 or 3 ISL

Exclusion Criteria:

  • Primary lymphedema stage 1, secondary lymphedema, Minimum 6 years, maximum 25

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922635


Contacts
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Contact: Isabelle IQ Quere, PhD +33467337028 i-quere@chu-montpellier.fr

Locations
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France
CHU Montpellier Recruiting
Montpellier, Herault, France, 34295
Contact: Isabelle IQ Quere, PhD    +33467337028    i-Quere@chu-montpellier.fr   
Principal Investigator: Isabelle IQ Quere, PHD         
Sub-Investigator: Sandrine SM Mestre, PhD         
CHU Montpellier Recruiting
Montpellier, Herault, France, 34295
Contact: Isabelle IQ Quere, PhD    +33467337028    i-quere@chu-montpellier.fr   
Principal Investigator: Isabelle IQ Quere, PhD         
Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Marseille
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01922635    
Other Study ID Numbers: 8967
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: December 2016
Keywords provided by University Hospital, Montpellier:
Primary lymphedema quality of life, genetic research