Clinical trial NCT02821039: Turkish Thoracic Society Usual Interstitial Pneumonia Registry Study
Official title: Turkish Thoracic Society Usual Interstitial Pneumonia Registry Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Idiopathic Pulmonary Fibrosis
Usual Interstitial Pneumonia
Keywords: Idiopathic Pulmonary Fibrosis, Usual Interstitial Pneumonia
Lead sponsor: Turkish Thoracic Society
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 1678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with IPF and other causes of UIP.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Understand and sign the informed consent document.
2. 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:

1. 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),
2. Histopathological findings inconsistent with UIP pattern (as defined by ATS/ERS/JRS/ALAT criteria).

Primary outcomes:
measure: Number of subjects enrolled with IPF and other causes of UIP
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: Adapazari
country: Turkey
facility: Sakarya University Faculty of Medicine
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Ataturk Chest Diseases and Chest Surgery Education and Research Hospital
city: Ankara
country: Turkey
facility: Atatürk Chest Disease and Chest Surgery Research and Training Hospital
city: Ankara
country: Turkey
facility: Dışkapı Yıldırım Beyazıt Training and Research Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Aydin
country: Turkey
facility: Adnan Menderes University Faculty of Medicine
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty
city: Diyarbakir
country: Turkey
facility: Dicle University Medical Faculty
city: Diyarbakir
country: Turkey
facility: Memorial Diyarbakir Hospital
city: Duzce
country: Turkey
facility: Duzce University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine
city: Erzurum
country: Turkey
facility: Atatürk University Faculty of Medicine
city: Erzurum
country: Turkey
facility: Atatürk University Medical Faculty
city: Istanbul
country: Turkey
facility: Dr.Lutfi Kirdar Kartal Education and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Koç University Medical Faculty
city: Istanbul
country: Turkey
facility: Sisli Florence Nightingale Hospital
city: Istanbul
country: Turkey
facility: Sureyyapasa Chest Diseases and Thoracic Surgery Education and Research Hospital
city: Istanbul
country: Turkey
facility: Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
city: Istanbul
country: Turkey
facility: Süreyyapasa Pulmonary Diseases and Thoracic Surgery Education and Research Hospital
city: Istanbul
country: Turkey
facility: Yedikule Chest Disease Education and Research Hospital
city: Istanbul
country: Turkey
facility: Yedikule Chest Diseases and Chest Surgery Education and Research Hospital
city: Istanbul
country: Turkey
facility: Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital
city: Istanbul
country: Turkey
facility: Yedikule Chest Diseases Education and Research Hospital
city: Istanbul
country: Turkey
facility: Yedikule Hospital for Chest Disease and Chest Surgery
city: Istanbul
country: Turkey
facility: Yedikule Hospital for Chest Disease and Thoracic Surgery
city: Istanbul
country: Turkey
facility: Yedikule Pulmonary Diseases Education and Research Hospital
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Izmir
country: Turkey
facility: Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital
city: Izmir
country: Turkey
facility: Dr. Suat Seren Pulmonary Diseases and Thoracic Surgery Training and Research Hospital
city: Izmir
country: Turkey
facility: Ege University Faculty of Medicine
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Kirikkale
country: Turkey
facility: Kirikkale University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Faculty of Medicine
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medical Faculty
Study officials:
affiliation: Istanbul University,Cerrahpasa Medical Faculty, Istanbul, Turkey.
name: Benan Müsellim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.