Adult Pulmonary Langerhans Cell HistiocytosisLCHA1NCT01225601
Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis
An observational study of Adult Pulmonary Langerhans Cell Histiocytosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Study objectives: To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis To assess the impact of tobacco discontinuation Study Design Multicentric prospective cohort study Main endpoint: Pulmonary deterioration Sample size : 40 patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Pulmonary Langerhans Cell Histiocytosis
- What is being tested?
- Tabacco discontinuation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Sep 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Pulmonary Langerhans cell histiocytosis
Who may be able to join
- Pulmonary Langerhans cell histiocytosis diagnosed within the past 48 months
Who cannot join
- Age < 18
- Deep pulmonary dysfunction (CPT< 60%, FEV1< 30%, DLCO< 30%, partial pressure of oxygen in arterial blood (PaO2)< 60mmHg)
- No informed consent or consent withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of Adult Adult Pulmonary Langerhans Cell Histiocytosis - A Multicenter Cohort Study
Study objectives:
- To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis
- To assess the impact of tobacco discontinuation
- Study Design Multicentric prospective cohort study
- Main endpoint: Pulmonary deterioration
- Sample size : 40 patients
Read the detailed description
Study objectives To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis To assess the impact of tobacco discontinuation Study Design Multicentric prospective cohort study Main endpoint: Pulmonary deterioration Sample size : 40 patients
- Being tested
- Tabacco discontinuation
- Medical subject headings
- Histiocytosis, Langerhans-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tabacco discontinuationBehavioural
Tabacco discontinuation
| Study group | Role | What they receive |
|---|---|---|
| Histocytosis | Adult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH) Receives: Behavioral: Tabacco discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary deterioration
decrease in Forced expiratory volume in 1 second (FEV1), vital capacity (VC), or Diffusing capacity of the lung for carbon monoxide (DLCO) of at least 15% as compared to baseline values and/or progression of clinical symptoms (general symptoms) and/or occurrence of pneumothorax
Measured: 2 years
Secondary outcomes (2)
Evolution of pulmonary volumes (FEV1)
Measured: 6 months
Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startMay 2006
- Primary completionMay 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adult Pulmonary Langerhans Cell HistiocytosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdellatif TAZI, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225601
- Sponsor's protocol ID
- AOM 04141
- Acronym
- LCHA1
- Status last verified
- Mar 2015
- First submitted
- 12 Oct 2010
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Tazi A, de Margerie C, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. The natural history of adult pulmonary Langerhans cell histiocytosis: a prospective multicentre study. Orphanet J Rare Dis. 2015 Mar 14;10:30. doi: 10.1186/s13023-015-0249-2.
PubMed 25887097Tazi A, de Margerie-Mellon C, Vercellino L, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. Extrathoracic investigation in adult patients with isolated pulmonary langerhans cell histiocytosis. Orphanet J Rare Dis. 2016 Feb 2;11:11. doi: 10.1186/s13023-016-0387-1.
PubMed 26833097
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Adult Adult Pulmonary Langerhans Cell Histiocytosis - A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT01225601
- Acronym / sponsor ID
- LCHA1 / AOM 04141
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Oct 2010 (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.
Study objectives:
- To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis
- To assess the impact of tobacco discontinuation
- Study Design Multicentric prospective cohort study
- Main endpoint: Pulmonary deterioration
- Sample size : 40 patients
Detailed description
Study objectives To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis To assess the impact of tobacco discontinuation Study Design Multicentric prospective cohort study Main endpoint: Pulmonary deterioration Sample size : 40 patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histocytosis | – | Behavioral: Tabacco discontinuationAdult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Pulmonary Langerhans cell histiocytosis
Key inclusion criteria (1 listed)
- Pulmonary Langerhans cell histiocytosis diagnosed within the past 48 months
Key exclusion criteria (3 listed)
- Age < 18
- Deep pulmonary dysfunction (CPT< 60%, FEV1< 30%, DLCO< 30%, partial pressure of oxygen in arterial blood (PaO2)< 60mmHg)
- No informed consent or consent withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tabacco discontinuationTabacco discontinuation | Behavioural | Histocytosis |
Primary outcome
Pulmonary deterioration
Time frame: 2 years
decrease in Forced expiratory volume in 1 second (FEV1), vital capacity (VC), or Diffusing capacity of the lung for carbon monoxide (DLCO) of at least 15% as compared to baseline values and/or progression of clinical symptoms (general symptoms) and/or occurrence of pneumothorax
2 secondary outcomes
Evolution of pulmonary volumes (FEV1)
Time frame: 6 months
Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT)
Time frame: 6 months
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 18 Apr 2016.
- Results publication: PubMed 25887097Tazi A, de Margerie C, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. The natural history of adult pulmonary Langerhans cell histiocytosis: a prospective multicentre study. Orphanet J Rare Dis. 2015 Mar 14;10:30. doi: 10.1186/s13023-015-0249-2.
- Derived from this study: PubMed 26833097Tazi A, de Margerie-Mellon C, Vercellino L, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. Extrathoracic investigation in adult patients with isolated pulmonary langerhans cell histiocytosis. Orphanet J Rare Dis. 2016 Feb 2;11:11. doi: 10.1186/s13023-016-0387-1.
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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.
Abdellatif TAZI, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Adult Pulmonary Langerhans Cell Histiocytosis, run by Assistance Publique - Hôpitaux de Paris 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 1 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 18 Apr 2016. 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.
What does the primary outcome measure?
Pulmonary deterioration (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01225601, which also lists 2 linked publications.
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 18 Apr 2016.