Pulmonary FibrosisNCT01501578
Pulmonary Fibrosis and Telomerase Mutation Study
An observational study of Pulmonary Fibrosis, run by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with pulmonary fibrosis with and without telomerase mutation
Who may be able to join
- Diffuse interstitial lung disease on CT scan
- Telomerase mutation analysis
Who cannot join
- Presence of connective tissue disease, or pneumoconiosis or drug induced lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenotype of Pulmonary Fibrosis Associated With a Mutation of Telomerase
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.
Read the 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.
- Conditions
- Pulmonary Fibrosis
- Keywords
- Pulmonary fibrosis, Telomerase mutation
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| telomerase mutation | Patients with interstitial lung disease and telomerase mutation | |
| control | Patients with idiopathic pulmonary fibrosis and without telomerase mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of imaging pattern
Description of imaging pattern on representative CT scan at diagnosis.
Measured: at baseline only
Secondary outcomes (2)
Pathology of the lung
description of pathological pattern
Measured: at baseline only
Pulmonary function tests
analyze the respiratory function
Measured: from diagnosis to last follow-up, for an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
- Sponsor type
- University, hospital or other
- Collaborators
- Bichat Hospital
- Responsible party
- Principal investigator, Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
- Investigators
- vincent Cottin, MD, Principal investigator, Hospices civils de Lyon / University Lyon I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501578
- Sponsor's protocol ID
- GERMOP-004
- Status last verified
- Feb 2018
- First submitted
- 13 Dec 2011
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Under analysis, publication in preparation
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype of Pulmonary Fibrosis Associated With a Mutation of Telomerase
- ClinicalTrials.gov ID
- NCT01501578
- Acronym / sponsor ID
- GERMOP-004
- Conditions
- Pulmonary Fibrosis
- Keywords
- Pulmonary fibrosis, Telomerase mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Groupe d'Etudes et de Recherche sur les Maladies Orphelines PulmonairesUniversity, hospital or other
- Collaborators
- Bichat Hospital
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telomerase mutation | – | –Patients with interstitial lung disease and telomerase mutation |
| control | – | –Patients with idiopathic pulmonary fibrosis and without telomerase mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pulmonary fibrosis with and without telomerase mutation
Key inclusion criteria (2 listed)
- Diffuse interstitial lung disease on CT scan
- Telomerase mutation analysis
Key exclusion criteria (1 listed)
- Presence of connective tissue disease, or pneumoconiosis or drug induced lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of imaging pattern
Time frame: at baseline only
Description of imaging pattern on representative CT scan at diagnosis.
2 secondary outcomes
Pathology of the lung
Time frame: at baseline only
Pulmonary function tests
Time frame: from diagnosis to last follow-up, for an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- website National French Reference Center for rare lung diseasesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Under analysis, publication in preparation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
vincent Cottin, MD principal investigator
Hospices civils de Lyon / University Lyon I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of imaging pattern (time frame: at baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.