NCT04665674

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2004Dec 2035

Study Start

First participant enrolled

January 1, 2004

Completed
16.9 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

December 17, 2020

Status Verified

November 1, 2020

Enrollment Period

31 years

First QC Date

November 30, 2020

Last Update Submit

December 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

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

    20 years

Secondary Outcomes (5)

  • CRF

    20 years

  • PH

    20 years

  • Malignant diseases

    20 years

  • Extra-pulmonary involvement in isolated PLCH

    20 years

  • Annual prevalence

    20 years

Study Arms (1)

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

Other: Standard of care

Interventions

Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)

Pulmonary Langerhans cell histiocytosis (PLCH)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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

You may qualify if:

  • Age \>= 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

French national reference centre for Histiocytoses

Paris, 75010, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HistiocytosisHistiocytosis, Langerhans-Cell

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Abdellatif TAZI, MD PhD

CONTACT

matthieu resche-rigon, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 11, 2020

Study Start

January 1, 2004

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2035

Last Updated

December 17, 2020

Record last verified: 2020-11

Locations