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

NCT ID: NCT04665674

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-01

Study Completion Date

2035-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Histiocytosis Histiocytosis, Langerhans-Cell Histiocytosis Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Langerhans cell histiocytosis (PLCH)

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

Standard of care

Intervention Type OTHER

Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)

Interventions

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Standard of care

Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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French national reference centre for Histiocytoses

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Abdellatif TAZI, MD PhD

Role: CONTACT

Phone: 142499198

Email: [email protected]

matthieu resche-rigon, MD PhD

Role: CONTACT

Phone: 142499742

Email: [email protected]

Facility Contacts

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Abdellatif TAZI, MD PhD

Role: primary

Matthieu RESCHE-RIGON, MD PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 34675043 (View on PubMed)

Other Identifiers

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2014_TAZI

Identifier Type: -

Identifier Source: org_study_id