LymphangioleiomyomatosisRE-LAM-CENCT01484236
National Lymphangioleiomyomatosis Registry, France
An observational study of Lymphangioleiomyomatosis, run by Vincent COTTIN at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphangioleiomyomatosis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lymphangioleiomyomatosis
Who may be able to join
- Patients with sporadic lymphangioleiomyomatosis or associated with Tuberous sclerosis.
- patients diagnosed or hospitalized or seen in consultation since 01/01/2008
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vincent Cottin, MD contact
Raphaële Guelminger, CRA contact
France1 site, 1 recruiting
- Recruiting
Hôpital Louis Pradel
Lyon, 69677
Vincent Cottin, MD, 33-427-857-700, vincent.cottin@chu-lyon.fr
Raphaële Guelminger, CRA, 33-472-357-074, registre.lam@gmail.com
About this study
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.
Read the 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
- Conditions
- Lymphangioleiomyomatosis
- Keywords
- Lymphangioleiomyomatosis
- Medical subject headings
- Lymphangioleiomyomatosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases
Determine incidence and prevalence of lymphangioleiomyomatosis.
Measured: 4 years
Secondary outcomes (3)
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)
Measured: 4 years
Progression-free survival
Determine the frequency of the various forms with mild to moderate or severe, and rapid or slow evolution.
Measured: 4 years
Progression-free survival
Determine applicability of diagnostic criteria proposed in 2009
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphangioleiomyomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vincent COTTIN
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor-investigator, Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
- Investigators
- Vincent Cottin, MD, Principal investigator, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484236
- Sponsor's protocol ID
- GERMOP-003
- Acronym
- RE-LAM-CE
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2011
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Lymphangioleiomyomatosis Registry, France
- ClinicalTrials.gov ID
- NCT01484236
- Acronym / sponsor ID
- RE-LAM-CE / GERMOP-003
- Conditions
- Lymphangioleiomyomatosis
- Keywords
- Lymphangioleiomyomatosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vincent COTTINUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- Jan 2012
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lymphangioleiomyomatosis
Key inclusion criteria (2 listed)
- Patients with sporadic lymphangioleiomyomatosis or associated with Tuberous sclerosis.
- patients diagnosed or hospitalized or seen in consultation since 01/01/2008
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of cases
Time frame: 4 years
Determine incidence and prevalence of lymphangioleiomyomatosis.
3 secondary outcomes
localisation of cases
Time frame: 4 years
Progression-free survival
Time frame: 4 years
Progression-free survival
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Related trials for Lymphangioleiomyomatosis
RecruitingPhase 1/2
Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
Lymphangioleiomyomatosis
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
TSC Biosample Repository and Natural History Database
Tuberous Sclerosis, Lymphangioleiomyomatosis
RecruitingObservational study
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)
Tuberous Sclerosis Complex, Lymphangioleiomyomatosis
RecruitingPhase 1
Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM)
Lymphangioleiomyomatosis (LAM), Lymphangioleiomyomatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Cottin, MD contact
Raphaële Guelminger, CRA contact
Vincent Cottin, MD principal investigator
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires, HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphangioleiomyomatosis, run by Vincent COTTIN at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Cottin, MD (33-427-857-700), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.