ClinicalTrials.gov record NCT01484236
National Lymphangioleiomyomatosis Registry, France
National Lymphangioleiomyomatosis Registry, France
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
A national registry that collects medical and demographic information from people with lymphangioleiomyomatosis. It aims to measure how common the disease is, describe diagnostic timing and care pathways, and document disease severity and progression.
What it is studying. How many people have lymphangioleiomyomatosis, where patients are managed, and how the disease progresses and varies in severity; plus whether the 2009 diagnostic criteria apply.
What the researchers hope to learn. Determine the incidence and prevalence of lymphangioleiomyomatosis; estimate what proportion of patients are managed at reference or excellence centers; describe variability in severity and progression; assess the applicability of the 2009 diagnostic criteria; provide baseline epidemiological and management information ahead of future clinical research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
A research assistant will collect and enter participants' medical and demographic information into a registry. Collected information includes timing and methods of diagnosis and detailed medical data, particularly about respiratory function and its progression; the registry will draw from several information sources to increase completeness. The registry record does not list any invasive study procedures.
How the study is structured. An observational registry with cross-sectional data collection. Research staff enter detailed medical information into a central database; the registry may be used to establish a future prospective cohort.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on lymphangioleiomyomatosis
Important dates
- Study start
- January 2012
- Primary completion
- December 2027 (estimated)
- Study completion
- December 2028 (estimated)
- Target enrollment
- 200 participants (estimated)
- Last updated on registry
- Sep 11, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Vincent COTTIN
- Collaborators
- Hospices Civils de Lyon
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Vincent Cottin, MD 📞 33-427-857-700
- Raphaële Guelminger, CRA 📞 33-472-357-074
Participating sites (1)
- Hôpital Louis PradelRecruiting
Lyon, 69677 · France
- Vincent Cottin, MD · 33-427-857-700 · vincent.cottin@chu-lyon.fr
- Raphaële Guelminger, CRA · 33-472-357-074 · registre.lam@gmail.com
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- prospective cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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