Trial record 3 of 3 for:    "Milroy disease"

Validation Lymphoqol (0)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Hospital, Montpellier
Sponsor:
Collaborator:
University Hospital, Marseille
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01922635
First received: August 12, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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).

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922635

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

Locations
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
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 22, 2014