Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis (LCHA1)

April 15, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Pulmonary Langerhans cell histiocytosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evolution of pulmonary volumes (FEV1)
Time Frame: 6 months
6 months
Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Abdellatif TAZI, MD PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM 04141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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