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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 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: October 16, 2013
Last verified: October 2013
  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:


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: December 2013 (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
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: NCT01484236

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

Locations
France
Hôpital Louis Pradel 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: October 16, 2013
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
Immune System Diseases
Immunoproliferative Disorders
Lymphangiomyoma
Lymphatic Diseases
Lymphatic Vessel Tumors
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Perivascular Epithelioid Cell Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014