National Lymphangioleiomyomatosis Registry, France

Lymphangioleiomyomatosis Clinical Trial

— RE-LAM-CE  

Official title:

National Lymphangioleiomyomatosis Registry, France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01484236
• Other study ID #: GERMOP-003
• Status: Recruiting
• Start date: January 2012
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
• Contact: Vincent Cottin, MD
• Phone: 33-427-857-700
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with sporadic lymphangioleiomyomatosis or associated with Tuberous sclerosis.

• patients diagnosed or hospitalized or seen in consultation since 01/01/2008

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Lymphangioleiomyomatosis

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Vincent COTTIN	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases	Determine incidence and prevalence of lymphangioleiomyomatosis.	4 years
Secondary	localisation of cases	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)	4 years
Secondary	Progression-free survival	Determine the frequency of the various forms with mild to moderate or severe, and rapid or slow evolution.	4 years
Secondary	Progression-free survival	Determine applicability of diagnostic criteria proposed in 2009	4 years