Adult Pulmonary Langerhans Cell Histiocytosis: a National... | NCT04665674

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

NCT04665674

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Recruiting

Last Update Posted

Dec 17, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Histiocytosis
Histiocytosis, Langerhans-Cell
Histiocytosis Pulmonary

Interventions

Standard of care

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2004Actual

Primary Completion Date

Dec 31, 2034Estimated

Completion Date

Dec 31, 2035Estimated

First Submitted Date

Nov 30, 2020

First Submission Date that Met QC Criteria

Dec 7, 2020

First Posted Date

Dec 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Standard of care	Other	Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)	Pulmonary Langerhans cell histiocytosis (PLCH)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival defined as the time from inclusion to death from any cause.	20 years

Secondary Outcomes

Measure	Description	Time Frame
CRF	Cumulative incidence of chronic respiratory failure (CRF) from inclusion	20 years
PH	Cumulative incidence of pulmonary hypertension (PH) from inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdellatif TAZI, MD PhD	Contact	142499198	33	abdellatif.tazi@aphp.fr
matthieu resche-rigon, MD PhD	Contact	142499742	33	matthieu.resche-rigon@u-paris.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
French national reference centre for Histiocytoses	Recruiting	Paris		75010	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34675043	Derived	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.

ID	Term
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Term
D015614	Histiocytosis
D006646	Histiocytosis, Langerhans-Cell