Pulmonary Fibrosis and Telomerase Mutation Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bichat Hospital
Information provided by (Responsible Party):
Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
ClinicalTrials.gov Identifier:
NCT01501578
First received: December 13, 2011
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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.


Condition
Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Phenotype of Pulmonary Fibrosis Associated With a Mutation of Telomerase

Resource links provided by NLM:


Further study details as provided by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires:

Primary Outcome Measures:
  • Description of imaging pattern [ Time Frame: at baseline only ] [ Designated as safety issue: No ]
    Description of imaging pattern on representative CT scan at diagnosis.


Secondary Outcome Measures:
  • Pathology of the lung [ Time Frame: at baseline only ] [ Designated as safety issue: No ]
    description of pathological pattern

  • Pulmonary function tests [ Time Frame: from diagnosis to last follow-up, for an average of one year ] [ Designated as safety issue: No ]
    analyze the respiratory function


Biospecimen Retention:   Samples With DNA

one blood sample is collected for genetic analysis of telomerase mutation


Estimated Enrollment: 66
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
telomerase mutation
Patients with interstitial lung disease and telomerase mutation
control
Patients with idiopathic pulmonary fibrosis and without telomerase mutation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with pulmonary fibrosis with and without telomerase mutation

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501578

Contacts
Contact: Vincent Cottin, MD 33-4-72-35-70-72 vincent.cottin@chu-lyon.fr
Contact: Raphaële Guelminger, CRA 33-4-72-35-70-74 raphaele.guelminger@chu-lyon.fr

Locations
France
Louis Pradel Hospital Recruiting
Lyon (Bron), France, 69677
Contact: Vincent Cottin, MD    33-4-72-35-70-72    vincent.cottin@chu-lyon.fr   
Contact: Raphaële Guelminger, CRA    33-4-72-35-70-74    raphaele.guelminger@chu-lyon.fr   
Principal Investigator: Vincent Cottin, MD         
Sponsors and Collaborators
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Bichat Hospital
Investigators
Principal Investigator: vincent Cottin, MD Hospices civils de Lyon / University Lyon I
  More Information

No publications provided

Responsible Party: Vincent COTTIN, Principal Investigator, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
ClinicalTrials.gov Identifier: NCT01501578     History of Changes
Other Study ID Numbers: GERMOP-004
Study First Received: December 13, 2011
Last Updated: December 27, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires:
Pulmonary fibrosis
Telomerase mutation

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014