Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis

NCT ID: NCT01225601

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adult Pulmonary Langerhans Cell Histiocytosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Histocytosis

Adult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH)

Tabacco discontinuation

Intervention Type BEHAVIORAL

Tabacco discontinuation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tabacco discontinuation

Tabacco discontinuation

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pulmonary Langerhans cell histiocytosis diagnosed within the past 48 months

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abdellatif TAZI, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Saint Louis

Paris, Paris, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25887097 (View on PubMed)

Tazi 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.

Reference Type DERIVED
PMID: 26833097 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AOM 04141

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

EMPHYSEMA AND FLNA MUTATION
NCT05550844 COMPLETED
Lung Health Study (LHS) I and III
NCT00000568 COMPLETED PHASE3