- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821039
Turkish Thoracic Society Usual Interstitial Pneumonia Registry Study (TURK-UIP)
September 23, 2019 updated by: Turkish Thoracic Society
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.
Study Overview
Status
Terminated
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 Type
Observational
Enrollment (Actual)
1678
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adana, Turkey
- Cukurova University Medical Faculty
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Adapazari, Turkey
- Sakarya University Faculty of Medicine
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Ankara, Turkey, MD
- Gazi University Medical Faculty
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Ankara, Turkey
- Ankara University Faculty of Medicine
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Ankara, Turkey
- Ankara University Medical Faculty
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Ankara, Turkey
- Ataturk Chest Diseases and Chest Surgery Education and Research Hospital
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Ankara, Turkey
- Atatürk Chest Disease and Chest Surgery Research and Training Hospital
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Ankara, Turkey
- Dışkapı Yıldırım Beyazıt training and research hospital
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Ankara, Turkey
- Gazi University Medical Faculty
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Antalya, Turkey
- Akdeniz University Medical Faculty
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Aydin, Turkey
- Adnan Menderes University Faculty of Medicine
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Bursa, Turkey
- Uludag University Medical Faculty
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Denizli, Turkey
- Pamukkale University Medical Faculty
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Diyarbakir, Turkey
- Dicle University Medical Faculty
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Diyarbakir, Turkey
- Memorial Diyarbakir Hospital
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Duzce, Turkey
- Duzce University Medical Faculty
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Edirne, Turkey
- Trakya University Faculty of Medicine
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Erzurum, Turkey
- ATATURK UNIVERSITY FACULTY OF MEDICINE
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Erzurum, Turkey
- Ataturk University Medical Faculty
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Istanbul, Turkey
- Dr.Lutfi Kirdar Kartal Education and Research Hospital
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Istanbul, Turkey
- Istanbul University Cerrahpasa Medical Faculty
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Istanbul, Turkey
- Istanbul University Istanbul Medical Faculty
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Istanbul, Turkey
- Istanbul University, Istanbul Medical Faculty
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Istanbul, Turkey
- Koç University Medical Faculty
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Istanbul, Turkey
- Sisli Florence Nightingale Hospital
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Istanbul, Turkey
- Sureyyapasa Chest Diseases and Thoracic Surgery Education and Research Hospital
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Istanbul, Turkey
- Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
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Istanbul, Turkey
- Süreyyapasa Pulmonary Diseases and Thoracic Surgery Education and Research Hospital
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Istanbul, Turkey
- Yedikule Chest Disease Education and Research Hospital
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Istanbul, Turkey
- Yedikule Chest Diseases and Chest Surgery Education and Research Hospital
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Istanbul, Turkey
- Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital
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Istanbul, Turkey
- Yedikule Chest Diseases Education and Research Hospital
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Istanbul, Turkey
- Yedikule Hospital for Chest Disease and Chest Surgery
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Istanbul, Turkey
- Yedikule Hospital for Chest Disease and Thoracic Surgery
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Istanbul, Turkey
- Yedikule Pulmonary Diseases Education and Research Hospital
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Izmir, Turkey
- Dokuz Eylul University Medical Faculty
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Izmir, Turkey
- Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital
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Izmir, Turkey
- Dr. Suat Seren Pulmonary Diseases and Thoracic Surgery Training and Research Hospital
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Izmir, Turkey
- Ege University Faculty of Medicine
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Izmir, Turkey
- Ege University Medical Faculty
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Kirikkale, Turkey
- Kirikkale University Medical Faculty
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Kocaeli, Turkey
- Kocaeli University Faculty of Medicine
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Kocaeli, Turkey
- Kocaeli University Medical Faculty
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Konya, Turkey
- Necmettin Erbakan University Meram Medical Faculty
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Samsun, Turkey
- Ondokuz Mayis University Medical Faculty
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Trabzon, Turkey
- Karadeniz Technical University Medical Faculty
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects diagnosed with IPF and other causes of UIP.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benan Müsellim, MD, Istanbul University,Cerrahpasa Medical Faculty, Istanbul, Turkey.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- American 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. Erratum In: Am J Respir Crit Care Med2002 Aug 1;166(3):426.
- Ryerson 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
July 8, 2019
Study Completion (Actual)
July 8, 2019
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
June 30, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Actual)
September 25, 2019
Last Update Submitted That Met QC Criteria
September 23, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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