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National Lymphangioleiomyomatosis Registry, France (RE-LAM-CE)

This study is not yet open for participant recruitment.
Verified December 2011 by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Sponsor:
Collaborator:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
ClinicalTrials.gov Identifier:
NCT01484236
First received: November 30, 2011
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Lymphangioleiomyomatosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: National Lymphangioleiomyomatosis Registry, France

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires:

Primary Outcome Measures:
  • Number of cases [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Determine incidence and prevalence of lymphangioleiomyomatosis.


Secondary Outcome Measures:
  • localisation of cases [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Determine applicability of diagnostic criteria proposed in 2009


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with lymphangioleiomyomatosis

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484236

Contacts
Contact: Vincent Cottin, MD 33-472-357-072
Contact: Raphaële Guelminger, CRA 33-472-357-074

Locations
France
Hôpital Louis Pradel Not yet recruiting
Lyon (Bron), France, 69677
Contact: Vincent Cottin, MD     33-472-357-072     vincent.cottin@chu-lyon.fr    
Contact: Raphaële Guelminger, CRA     33-472-357-074     registre.lam@gmail.com    
Sponsors and Collaborators
Vincent COTTIN
Hospices Civils de Lyon
Investigators
Principal Investigator: Vincent Cottin, MD Groupe d'Etudes et de Recherche sur les Maladie Orpheline
  More Information

No publications provided

Responsible Party: Vincent COTTIN, Professor V. Cottin, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
ClinicalTrials.gov Identifier: NCT01484236     History of Changes
Other Study ID Numbers: GERMOP-003
Study First Received: November 30, 2011
Last Updated: December 12, 2011
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes

Keywords provided by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires:
Lymphangioleiomyomatosis

Additional relevant MeSH terms:
Lymphangioleiomyomatosis
Lymphangiomyoma
Lymphatic Vessel Tumors
Neoplasms by Histologic Type
Neoplasms
Perivascular Epithelioid Cell Neoplasms
 Neoplasms, Connective and Soft Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013