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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: April 15, 2016
Last verified: March 2015

October 12, 2010
April 15, 2016
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 ]
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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
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Non-Probability Sample
Adult Pulmonary Langerhans cell histiocytosis
Adult Pulmonary Langerhans Cell Histiocytosis
Behavioral: Tabacco discontinuation
Tabacco discontinuation
Histocytosis
Adult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH)
Intervention: Behavioral: Tabacco discontinuation
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.

*   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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01225601
AOM 04141
No
Not Provided
Not Provided
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
March 2015

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