LymphangioleiomyomatosisLAM-PHNCT00960895
Pulmonary Hypertension in Lymphangioleiomyomatosis
An observational study of Lymphangioleiomyomatosis and Pulmonary Hypertension, run by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires at 1 site in France.
Trial summary
This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphangioleiomyomatosis, Pulmonary Hypertension
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Lymphangioleiomyomatosis, either sporadic or associated with tuberous sclerosis Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)
Who may be able to join
- Lymphangioleiomyomatosis (definite or probable), either sporadic or associated with tuberous sclerosis
- Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)
Who cannot join
- Post capillary pulmonary hypertension
- Other identifiable causes of pulmonary hypertension (ex: thromboembolic disease)
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Patients With Lymphangioleiomyomatosis and Pulmonary Hypertension
This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension.
Read the detailed description
Descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension This will include modality of diagnosis of lLymphangioleiomyomatosis, results of right-sided heart catheterization, and pulmonary function tests
- Conditions
- Lymphangioleiomyomatosis, Pulmonary Hypertension
- Keywords
- Lymphangioleiomyomatosis, Pulmonary hypertension
- Medical subject headings
- Lymphangioleiomyomatosis, Hypertension, Pulmonary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2010
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Principal investigator, Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
- Investigators
- Vincent Cottin, MD, Principal investigator, University of Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960895
- Sponsor's protocol ID
- GERMOP-001
- Acronym
- LAM-PH
- Status last verified
- Oct 2011
- First submitted
- 17 Aug 2009
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Patients With Lymphangioleiomyomatosis and Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00960895
- Acronym / sponsor ID
- LAM-PH / GERMOP-001
- Conditions
- Lymphangioleiomyomatosis, Pulmonary Hypertension
- Keywords
- Lymphangioleiomyomatosis, Pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Groupe d'Etudes et de Recherche sur les Maladies Orphelines PulmonairesUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Aug 2009 (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.
This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension.
Detailed description
Descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension This will include modality of diagnosis of lLymphangioleiomyomatosis, results of right-sided heart catheterization, and pulmonary function tests
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lymphangioleiomyomatosis, either sporadic or associated with tuberous sclerosis Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)
Key inclusion criteria (2 listed)
- Lymphangioleiomyomatosis (definite or probable), either sporadic or associated with tuberous sclerosis
- Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)
Key exclusion criteria (3 listed)
- Post capillary pulmonary hypertension
- Other identifiable causes of pulmonary hypertension (ex: thromboembolic disease)
- Not willing to participate
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
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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. This study is not recruiting at the moment.
Vincent Cottin, MD principal investigator
University of Lyon
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 and Pulmonary Hypertension, run by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires 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 3 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: finished, as of the sponsor's last update on 27 Oct 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 27 Oct 2011.