National Lymphangioleiomyomatosis Registry, France

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01484236
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vincent COTTIN
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vincent Cottin, MD
Principal Investigator Affiliation Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires, HCL
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lymphangioleiomyomatosis
Additional Details

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

Contact a Trial Team

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International Sites

Hôpital Louis Pradel, Lyon, France

Status

Recruiting

Address

Hôpital Louis Pradel

Lyon, , 69677

Site Contact

Vincent Cottin, MD

vincent.cottin@chu-lyon.fr

33-427-857-700

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