Pulmonary Fibrosis and Telomerase Mutation Study
This study is currently recruiting participants.
Verified December 2011 by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Sponsor:
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
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
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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
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 May 19, 2013