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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01501578
Other study ID # GERMOP-004
Secondary ID
Status Completed
Phase N/A
First received December 13, 2011
Last updated February 19, 2018
Start date December 2011
Est. completion date December 2015

Study information

Verified date February 2018
Source Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date December 2015
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Louis Pradel Hospital (Bâtiment A4) Lyon

Sponsors (2)

Lead Sponsor Collaborator
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires Bichat Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of imaging pattern Description of imaging pattern on representative CT scan at diagnosis. at baseline only
Secondary Pathology of the lung description of pathological pattern at baseline only
Secondary Pulmonary function tests analyze the respiratory function from diagnosis to last follow-up, for an average of one year
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