National Lymphangioleiomyomatosis Registry, France (RE-LAM-CE)
RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic information and information concerning the timing and modalities of diagnosis.
Based on the registry, we will set up a prospective cohort of patients. The database will include detailed medical information, particularly regarding progression of the respiratory function.
|Study Design:||Observational Model: Other
Time Perspective: Cross-Sectional
|Official Title:||National Lymphangioleiomyomatosis Registry, France|
- Number of cases [ Time Frame: 4 years ]Determine incidence and prevalence of lymphangioleiomyomatosis.
- localisation of cases [ Time Frame: 4 years ]Estimate the proportion of patients with lymphangioleiomyomatosis who are managed by the Reference Center and Centers of excellence for rare lung diseases in France (coverage rate of centers)
- Progression-free survival [ Time Frame: 4 years ]Determine the frequency of the various forms with mild to moderate or severe, and rapid or slow evolution.
- Progression-free survival [ Time Frame: 4 years ]Determine applicability of diagnostic criteria proposed in 2009
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Lymphangioleiomyomatosis is a rare pulmonary disease occuring preferentially in women. Few data are available regarding the epidemiology of this disease, the frequency of the various forms with mild to moderate or severe disease, and the rapid or slow progression.
Several sources of information will be used in order to increase completeness. The registry will also allow to estimate the proportion of patients with lymphangioleiomyomatosis who are managed by the Reference Center and Competence Centers for rare lung diseases in France.
Data will be collected by a research assistant, and the study will be coordinated by the Pole IMER - Department of Public health and Epidemiology of HCL (Lyon Hospitals).
This study will provide a better knowledge on the natural course of the disease and the variability in severity and progression of lymphangioleiomyomatosis, and the applicability of diagnostic criteria proposed in 2009. This study will provide the first detailed epidemiological information on Lymphangioleiomyomatosis, will assess the management of this rare disease within the French National Plan for rare diseases 2005 - 2009, and will provide valuable medical information prior to the establishment of clinical trials
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484236
|Contact: Vincent Cottin, MD||33-472-357-072|
|Contact: Raphaële Guelminger, CRA||33-472-357-074|
|Hôpital Louis Pradel||Recruiting|
|Lyon (Bron), France, 69677|
|Contact: Vincent Cottin, MD 33-472-357-072 firstname.lastname@example.org|
|Contact: Raphaële Guelminger, CRA 33-472-357-074 email@example.com|
|Principal Investigator:||Vincent Cottin, MD||Groupe d'Etudes et de Recherche sur les Maladie Orpheline|