Idiopathic Pulmonary FibrosisTURK-UIPNCT02821039
Turkish Thoracic Society Usual Interstitial Pneumonia Registry Study
An observational study of Idiopathic Pulmonary Fibrosis and Usual Interstitial Pneumonia, run by Turkish Thoracic Society at 46 sites in Turkey (Türkiye).
Trial summary
The Turkish Thoracic Society Usual Interstitial Pneumonia Registry (TURK-UIP) is a collaborative project to coordinate a team of investigators from various regions of Turkey. The purpose of the Registry is to collect epidemiological data on patients with idiopathic pulmonary fibrosis and other causes of UIP, and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Usual Interstitial Pneumonia
- How many people
- 1,678 participants
- Where
- 46 sitesTurkey (Türkiye)
- Study dates
- Jun 2016to 8 Jul 2019
- How long will I take part?
- 3 Years
- 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: Subjects diagnosed with IPF and other causes of UIP.
Who may be able to join
- Understand and sign the informed consent document.
- The presence of a definite or possible UIP pattern on high resolution computed tomography (HRCT) or a histologic UIP pattern (definite, probable and possible) on surgical lung biopsy (as defined by ATS/ERS/JRS/ALAT criteria).
Who cannot join
- HRCT findings inconsistent with UIP pattern (peribronchovascular predominance, extensive ground glass abnormality,profuse micronodules, discrete cysts , consolidation in bronchopulmonary segment(s)/lobe(s), diffuse mosaic attenuation/air-trapping),
- Histopathological findings inconsistent with UIP pattern (as defined by ATS/ERS/JRS/ALAT criteria).
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
Turkey (Türkiye)46 sites
Cukurova University Medical Faculty
Adana
Sakarya University Faculty of Medicine
Adapazarı
Gazi University Medical Faculty
Ankara, MD
Ankara University Faculty of Medicine
Ankara
Ankara University Medical Faculty
Ankara
Ataturk Chest Diseases and Chest Surgery Education and Research Hospital
Ankara
Atatürk Chest Disease and Chest Surgery Research and Training Hospital
Ankara
Dışkapı Yıldırım Beyazıt Training and Research Hospital
Ankara
Gazi University Medical Faculty
Ankara
Akdeniz University Medical Faculty
Antalya
Adnan Menderes University Faculty of Medicine
Aydin
Uludag University Medical Faculty
Bursa
Pamukkale University Medical Faculty
Denizli
Dicle University Medical Faculty
Diyarbakır
Memorial Diyarbakir Hospital
Diyarbakır
Duzce University Medical Faculty
Düzce
Trakya University Faculty of Medicine
Edirne
Atatürk University Faculty of Medicine
Erzurum
Atatürk University Medical Faculty
Erzurum
Dr.Lutfi Kirdar Kartal Education and Research Hospital
Istanbul
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Istanbul University Istanbul Medical Faculty
Istanbul
Istanbul University, Istanbul Medical Faculty
Istanbul
Koç University Medical Faculty
Istanbul
Sisli Florence Nightingale Hospital
Istanbul
Sureyyapasa Chest Diseases and Thoracic Surgery Education and Research Hospital
Istanbul
Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
Süreyyapasa Pulmonary Diseases and Thoracic Surgery Education and Research Hospital
Istanbul
Yedikule Chest Disease Education and Research Hospital
Istanbul
Yedikule Chest Diseases and Chest Surgery Education and Research Hospital
Istanbul
Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital
Istanbul
Yedikule Chest Diseases Education and Research Hospital
Istanbul
Yedikule Hospital for Chest Disease and Chest Surgery
Istanbul
Yedikule Hospital for Chest Disease and Thoracic Surgery
Istanbul
Yedikule Pulmonary Diseases Education and Research Hospital
Istanbul
Dokuz Eylul University Medical Faculty
Izmir
Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital
Izmir
Dr. Suat Seren Pulmonary Diseases and Thoracic Surgery Training and Research Hospital
Izmir
Ege University Faculty of Medicine
Izmir
Ege University Medical Faculty
Izmir
Kirikkale University Medical Faculty
Kirikkale
Kocaeli University Faculty of Medicine
Kocaeli
Kocaeli University Medical Faculty
Kocaeli
Necmettin Erbakan University Meram Medical Faculty
Konya
Ondokuz Mayis University Medical Faculty
Samsun
Karadeniz Technical University Medical Faculty
Trabzon
About this study
The Turkish Thoracic Society Usual Interstitial Pneumonia Registry (TURK-UIP) is a collaborative project to coordinate a team of investigators from various regions of Turkey. The purpose of the Registry is to collect epidemiological data on patients with idiopathic pulmonary fibrosis and other causes of UIP, and to obtain information about the natural course of the disease and the treatment response.
Read the detailed description
The TURK-UIP Registry is a web based application that will store information about patients. A HRCT pattern consistent with UIP will be confirmed by 3 radiologists. At the 3-month visits, the pulmonary function tests and the 6-minute walk test will be recorded. Patients will be prospectively followed for a 5-year period.
- Keywords
- Idiopathic Pulmonary Fibrosis, Usual Interstitial Pneumonia
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects enrolled with IPF and other causes of UIP
Natural history of course of disease in patients with IPF and other causes of UIP.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion8 Jul 2019
- Study completion8 Jul 2019
Why it stopped: We decided to complete our research in the 4th year, and publish the data. The data are under evaluation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,678 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Turkish Thoracic Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benan Müsellim, MD, Principal investigator, Istanbul University,Cerrahpasa Medical Faculty, Istanbul, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821039
- Sponsor's protocol ID
- TTS-01
- Acronym
- TURK-UIP
- Status last verified
- Sep 2019
- First submitted
- 29 Jun 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
PubMed 21471066American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
PubMed 11790668Ryerson CJ, Corte TJ, Collard HR, Richeldi L. A global registry for idiopathic pulmonary fibrosis: the time is now. Eur Respir J. 2014 Aug;44(2):273-6. doi: 10.1183/09031936.00051914. No abstract available.
PubMed 25082902
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Thoracic Society Usual Interstitial Pneumonia Registry Study
- ClinicalTrials.gov ID
- NCT02821039
- Acronym / sponsor ID
- TURK-UIP / TTS-01
- Keywords
- Idiopathic Pulmonary Fibrosis, Usual Interstitial Pneumonia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We decided to complete our research in the 4th year, and publish the data. The data are under evaluation.
- Enrolment
- 1,678 participants (actual)
- Lead sponsor
- Turkish Thoracic SocietyUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 1 Jul 2016 (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.
The Turkish Thoracic Society Usual Interstitial Pneumonia Registry (TURK-UIP) is a collaborative project to coordinate a team of investigators from various regions of Turkey. The purpose of the Registry is to collect epidemiological data on patients with idiopathic pulmonary fibrosis and other causes of UIP, and to obtain information about the natural course of the disease and the treatment response.
Detailed description
The TURK-UIP Registry is a web based application that will store information about patients. A HRCT pattern consistent with UIP will be confirmed by 3 radiologists. At the 3-month visits, the pulmonary function tests and the 6-minute walk test will be recorded. Patients will be prospectively followed for a 5-year period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with IPF and other causes of UIP.
Key inclusion criteria (2 listed)
- Understand and sign the informed consent document.
- The presence of a definite or possible UIP pattern on high resolution computed tomography (HRCT) or a histologic UIP pattern (definite, probable and possible) on surgical lung biopsy (as defined by ATS/ERS/JRS/ALAT criteria).
Key exclusion criteria (2 listed)
- HRCT findings inconsistent with UIP pattern (peribronchovascular predominance, extensive ground glass abnormality,profuse micronodules, discrete cysts , consolidation in bronchopulmonary segment(s)/lobe(s), diffuse mosaic attenuation/air-trapping),
- Histopathological findings inconsistent with UIP pattern (as defined by ATS/ERS/JRS/ALAT criteria).
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
Number of subjects enrolled with IPF and other causes of UIP
Time frame: 5 years
Natural history of course of disease in patients with IPF and other causes of UIP.
Results and safety
The study was stopped early (reason given: We decided to complete our research in the 4th year, and publish the data. The data are under evaluation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 21471066Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Background: PubMed 11790668American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
- Background: PubMed 25082902Ryerson CJ, Corte TJ, Collard HR, Richeldi L. A global registry for idiopathic pulmonary fibrosis: the time is now. Eur Respir J. 2014 Aug;44(2):273-6. doi: 10.1183/09031936.00051914. No abstract available.
- Individual participant dataSharing planned: No
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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.
Benan Müsellim, MD principal investigator
Istanbul University,Cerrahpasa Medical Faculty, Istanbul, Turkey.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Usual Interstitial Pneumonia, run by Turkish Thoracic Society at 46 sites in Turkey (Türkiye).
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 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: stopped early, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Turkey (Türkiye). 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 was stopped early (reason given: We decided to complete our research in the 4th year, and publish the data. The data are under evaluation.). Results are not available in the source record.
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?
Number of subjects enrolled with IPF and other causes of UIP (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02821039, which also lists 3 linked publications.
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 25 Sep 2019.