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Recruiting NCT04665674

Adult Pulmonary Langerhans Cell Histiocytosis: a National Registry-based Prospective Cohort Study

Observational Histiocytosis Histiocytosis, Langerhans-Cell Histiocytosis Pulmonary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of care.
Who it may be relevant to
Registry conditions: Histiocytosis, Histiocytosis, Langerhans-Cell, Histiocytosis Pulmonary. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Enquête épidémiologique Sur la prévalence et le Pronostic de l'Histiocytose Langerhansienne Pulmonaire de l'Adulte en France

Overview

The long-term outcomes of adult patients with pulmonary Langerhans cell histiocytosis (PLCH), particularly survival, is largely unknown. This is the first prospective study in the field evaluating the long-term outcomes of PLCH patients. This french countrywide registry-based study included a large cohort of PLCH patients followed for a sufficiently long period to address risk factors of long-term outcomes of PLCH patients.

Interventions

  • Other Standard of care
    Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)

Primary outcome measures

  • Overall survival [Time frame: 20 years]
Secondary outcome measures (5)
  • CRF [Time frame: 20 years]
  • PH [Time frame: 20 years]
  • Malignant diseases [Time frame: 20 years]
  • Extra-pulmonary involvement in isolated PLCH [Time frame: 20 years]
  • Annual prevalence [Time frame: 20 years]

Eligibility criteria

Inclusion criteria

  • Age >= 18 years
  • Diagnosis of PLCH was either histologically confirmed on a biopsy of an involved tissue, or based on the combination of the following criteria: 1) an appropriate clinical picture; 2) a typical nodulo-cystic pattern on lung high-resolution computed tomography (HRCT) and 3) exclusion of alternative diagnoses

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • French national reference centre for Histiocytoses — Paris

Publications

  • Benattia A, Bugnet E, Walter-Petrich A, de Margerie-Mellon C, Meignin V, Seguin-Givelet A, Lorillon G, Chevret S, Tazi A. Long-term outcomes of adult pulmonary Langerhans cell histiocytosis: a prospective cohort. Eur Respir J. 2022 May 26;59(5):2101017. doi: 10.1183/13993003.01017-2021. Print 2022 May. PMID 34675043

Identifiers

NCT: NCT04665674 · 2014_TAZI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗