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NCT Number: NCT04665674

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

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.

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Key information

Conditions

Histiocytosis Hemic and Lymphatic Diseases Histiocytosis Pulmonary Histiocytosis, Langerhans-Cell Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Standard of care

Other

Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)

Primary outcomes

  1. Overall survival

    Time frame: 20 years

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

Secondary outcomes

  1. CRF

    Time frame: 20 years

    Cumulative incidence of chronic respiratory failure (CRF) from inclusion

  2. PH

    Time frame: 20 years

    Cumulative incidence of pulmonary hypertension (PH) from inclusion

  3. Malignant diseases

    Time frame: 20 years

    Cumulative incidence of Malignant diseases from inclusion

  4. Extra-pulmonary involvement in isolated PLCH

    Time frame: 20 years

    Cumulative incidence of extra pulmonary localisations from inclusion

  5. Annual prevalence

    Time frame: 20 years

    Number of people with the disease at any time during a year

Study contacts

Contact information is provided by the study sponsor or research team.

Abdellatif TAZI, MD PhD

CONTACT

[email protected]

142499198 ext. 33

matthieu resche-rigon, MD PhD

CONTACT

[email protected]

142499742 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2034
Study completion
2035
First posted
Dec 11, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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