Pulmonary Fibrosis and Telomerase Mutation Study | NCT01501578

Studies
Pulmonary Fibrosis and Telomerase Mutation Study

NCT01501578

Sponsor

Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires

Status

Completed

Last Update Posted

Feb 20, 2018Actual

Enrollment

81Actual

Phase

Not provided

Conditions

Pulmonary Fibrosis

Interventions

Not provided

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 13, 2011

First Submission Date that Met QC Criteria

Dec 27, 2011

First Posted Date

Dec 29, 2011Estimated

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

Feb 19, 2018

Last Update Posted Date

Feb 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vincent COTTIN, Principal Investigator, Groupe d'Etudes et de Recherche sur les Maladies Orphelines PulmonairesPrincipal Investigator

Lead Sponsor

Groupe d'Etudes et de Recherche sur les Maladies Orphelines PulmonairesOTHER

Collaborators

Name	Class
Bichat Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study is an observational and retrospective study of patients with pulmonary fibrosis associated or not with telomerase mutation.

The purpose of this study is to describe in detail the cases with telomerase mutation in terms of features on CT scan, respiratory function and evolution, in comparison to control subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family history.

Detailed Description

Two "control" subjects will be enrolled for one subject with telomerase mutation.

The data are all the results of investigations conducted for the diagnosis of idiopathic pulmonary fibrosis and during routine follow up of patients.

The CT scans will reviewed centrally to homogenize the description.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
telomerase mutation		Patients with interstitial lung disease and telomerase mutation
control		Patients with idiopathic pulmonary fibrosis and without telomerase mutation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description of imaging pattern	Description of imaging pattern on representative CT scan at diagnosis.	at baseline only

Secondary Outcomes

Measure	Description	Time Frame
Pathology of the lung	description of pathological pattern	at baseline only
Pulmonary function tests	analyze the respiratory function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diffuse interstitial lung disease on CT scan
Telomerase mutation analysis

Exclusion Criteria:

Presence of connective tissue disease, or pneumoconiosis or drug induced lung disease

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

patients with pulmonary fibrosis with and without telomerase mutation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
vincent Cottin, MD	Hospices civils de Lyon / University Lyon I	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Louis Pradel Hospital (Bâtiment A4)		Lyon		69677	France

References Module

Citations

Not provided

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005355	Fibrosis