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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04665674
Other study ID # 2014_TAZI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2004
Est. completion date December 31, 2035

Study information

Verified date November 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Abdellatif TAZI, MD PhD
Phone 142499198
Email abdellatif.tazi@aphp.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2035
Est. primary completion date December 31, 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: -

Study Design


Intervention

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

Locations

Country Name City State
France French national reference centre for Histiocytoses Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival Overall survival defined as the time from inclusion to death from any cause. 20 years
Secondary CRF Cumulative incidence of chronic respiratory failure (CRF) from inclusion 20 years
Secondary PH Cumulative incidence of pulmonary hypertension (PH) from inclusion 20 years
Secondary Malignant diseases Cumulative incidence of Malignant diseases from inclusion 20 years
Secondary Extra-pulmonary involvement in isolated PLCH Cumulative incidence of extra pulmonary localisations from inclusion 20 years
Secondary Annual prevalence Number of people with the disease at any time during a year 20 years
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