Interstitial Lung DiseaseNCT01809574
The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Meir Medical Center at 1 site in Israel.
Trial summary
We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients would lead to a more accurate diagnosis and consequently alterations in treatment regimens that may lead to improved outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Connective Tissue Disease
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Mar 2016
- 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: 60 patients that will refer to the pulmonary outpatient or inpatients department for evaluation due to ILD will be included
Who may be able to join
- Age above 18 years old
- ILD according to ATS/ERS guidelines
- Signed inform consent
Who cannot join
- Previous lung surgery
- Other significant systemic disease
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, Israel, 972
David Shitrit, Dr, 09-7471556, davids3@clalit.org.il
About this study
We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients would lead to a more accurate diagnosis and consequently alterations in treatment regimens that may lead to improved outcomes.
- Keywords
- Interstitial lung disease, Idiopathic pulmonary fibrosis, Connective tissue disease
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Connective Tissue Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with collagen related pulmonary fibrosis that are diagnosed by Rheumatologists compared to Pulmonologists.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Shitrit, Dr, Principal investigator, Head of Pulmonary departmant, Meir Medical Center.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809574
- Sponsor's protocol ID
- 225-12-MMC
- Status last verified
- Oct 2013
- First submitted
- 10 Mar 2013
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT01809574
- Acronym / sponsor ID
- 225-12-MMC
- Keywords
- Interstitial lung disease, Idiopathic pulmonary fibrosis, Connective tissue disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 12 Mar 2013 (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.
We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients would lead to a more accurate diagnosis and consequently alterations in treatment regimens that may lead to improved outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients that will refer to the pulmonary outpatient or inpatients department for evaluation due to ILD will be included
Key inclusion criteria (3 listed)
- Age above 18 years old
- ILD according to ATS/ERS guidelines
- Signed inform consent
Key exclusion criteria (2 listed)
- Previous lung surgery
- Other significant systemic 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
The number of patients with collagen related pulmonary fibrosis that are diagnosed by Rheumatologists compared to Pulmonologists.
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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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.
David Shitrit, Dr principal investigator
Head of Pulmonary departmant, Meir Medical Center.
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 Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Meir Medical Center at 1 site in Israel.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Apr 2015. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Shitrit, Dr. (097471556, davids3@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with collagen related pulmonary fibrosis that are diagnosed by Rheumatologists compared to Pulmonologists. (time frame: two years). 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 9 Apr 2015.