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Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis (LCHA1)

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ClinicalTrials.gov Identifier: NCT01225601
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment
Adult Pulmonary Langerhans Cell Histiocytosis Behavioral: Tabacco discontinuation

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

Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Adult Adult Pulmonary Langerhans Cell Histiocytosis - A Multicenter Cohort Study
Study Start Date : May 2006
Primary Completion Date : May 2009
Study Completion Date : September 2010


Groups and Cohorts

Group/Cohort Intervention/treatment
Histocytosis
Adult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH)
Behavioral: Tabacco discontinuation
Tabacco discontinuation


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evolution of pulmonary volumes (FEV1) [ Time Frame: 6 months ]
  2. Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT) [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Pulmonary Langerhans cell histiocytosis
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225601


Locations
France
Hôpital Saint Louis
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Abdellatif TAZI, MD PhD Assistance Publique - Hôpitaux de Paris
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01225601     History of Changes
Other Study ID Numbers: AOM 04141
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: March 2015

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases