Text Size

Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis (LCHA1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01225601
First received: October 12, 2010
Last updated: November 19, 2012
Last verified: November 2012
History of Changes

October 12, 2010
November 19, 2012
May 2006
May 2009   (final data collection date for primary outcome measure)
Pulmonary deterioration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
Pulmonary deterioration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
decrease in FEV1, VC, or DLCO of at least 15% as compared to baseline values and/or progression of clinical symptoms (general symptoms) and/or occurrence of pneumothorax
Complete list of historical versions of study NCT01225601 on ClinicalTrials.gov Archive Site
  • Evolution of pulmonary volumes (FEV1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis
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

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adult Pulmonary Langerhans cell histiocytosis
Adult Pulmonary Langerhans Cell Histiocytosis
Behavioral: Tabacco discontinuation
Tabacco discontinuation
Other Name: Tabacco discontinuation
Histocytosis
Adult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH)
Intervention: Behavioral: Tabacco discontinuation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
September 2010
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01225601
AOM 04141
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Abdellatif TAZI, MD PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP