National Lymphangioleiomyomatosis Registry, France (RE-LAM-CE)
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|ClinicalTrials.gov Identifier: NCT01484236|
Recruitment Status : Recruiting
First Posted : December 2, 2011
Last Update Posted : February 6, 2020
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.
|Condition or disease|
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
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||National Lymphangioleiomyomatosis Registry, France|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- 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
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): NCT01484236
|Contact: Vincent Cottin, MD||33-427-857-700|
|Contact: Raphaële Guelminger, CRA||33-472-357-074|
|Principal Investigator:||Vincent Cottin, MD||Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires, HCL|