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

ConditionsHistiocytosisHistiocytosis, Langerhans-CellHistiocytosis Pulmonary
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

All patients with newly diagnosed PLCH at adulthood (i.e. 18 years of age or older) referred to the French national reference centre for Histiocytoses

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard of care

    Other intervention

    Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Pulmonary Langerhans cell histiocytosis (PLCH)1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Overall survival defined as the time from inclusion to death from any cause.

Time frame
20 years

Secondary outcomes

1

CRF

Cumulative incidence of chronic respiratory failure (CRF) from inclusion

Time frame
20 years
2

PH

Cumulative incidence of pulmonary hypertension (PH) from inclusion

Time frame
20 years
3

Malignant diseases

Cumulative incidence of Malignant diseases from inclusion

Time frame
20 years
4

Extra-pulmonary involvement in isolated PLCH

Cumulative incidence of extra pulmonary localisations from inclusion

Time frame
20 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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