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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02821039
Other study ID # TTS-01
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 2016
Est. completion date July 8, 2019

Study information

Verified date September 2019
Source Turkish Thoracic Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 obtain information about the natural course of the disease and the treatment response.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1678
Est. completion date July 8, 2019
Est. primary completion date July 8, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Locations

Country Name City State
Turkey Cukurova University Medical Faculty Adana
Turkey Sakarya University Faculty of Medicine Adapazari
Turkey Ankara University Faculty of Medicine Ankara
Turkey Ankara University Medical Faculty Ankara
Turkey Atatürk Chest Disease and Chest Surgery Research and Training Hospital Ankara
Turkey Ataturk Chest Diseases and Chest Surgery Education and Research Hospital Ankara
Turkey Diskapi Yildirim Beyazit Training and Research Hospital Ankara
Turkey Gazi University Medical Faculty Ankara
Turkey Gazi University Medical Faculty Ankara
Turkey Akdeniz University Medical Faculty Antalya
Turkey Adnan Menderes University Faculty of Medicine Aydin
Turkey Uludag University Medical Faculty Bursa
Turkey Pamukkale University Medical Faculty Denizli
Turkey Dicle University Medical Faculty Diyarbakir
Turkey Memorial Diyarbakir Hospital Diyarbakir
Turkey Duzce University Medical Faculty Duzce
Turkey Trakya University Faculty of Medicine Edirne
Turkey Atatürk University Faculty of Medicine Erzurum
Turkey Atatürk University Medical Faculty Erzurum
Turkey Dr.Lutfi Kirdar Kartal Education and Research Hospital Istanbul
Turkey Istanbul University Cerrahpasa Medical Faculty Istanbul
Turkey Istanbul University Istanbul Medical Faculty Istanbul
Turkey Istanbul University, Istanbul Medical Faculty Istanbul
Turkey Koç University Medical Faculty Istanbul
Turkey Sisli Florence Nightingale Hospital Istanbul
Turkey Sureyyapasa Chest Diseases and Thoracic Surgery Education and Research Hospital Istanbul
Turkey Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul
Turkey Süreyyapasa Pulmonary Diseases and Thoracic Surgery Education and Research Hospital Istanbul
Turkey Yedikule Chest Disease Education and Research Hospital Istanbul
Turkey Yedikule Chest Diseases and Chest Surgery Education and Research Hospital Istanbul
Turkey Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital Istanbul
Turkey Yedikule Chest Diseases Education and Research Hospital Istanbul
Turkey Yedikule Hospital for Chest Disease and Chest Surgery Istanbul
Turkey Yedikule Hospital for Chest Disease and Thoracic Surgery Istanbul
Turkey Yedikule Pulmonary Diseases Education and Research Hospital Istanbul
Turkey Dokuz Eylul University Medical Faculty Izmir
Turkey Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital Izmir
Turkey Dr. Suat Seren Pulmonary Diseases and Thoracic Surgery Training and Research Hospital Izmir
Turkey Ege University Faculty of Medicine Izmir
Turkey Ege University Medical Faculty Izmir
Turkey Kirikkale University Medical Faculty Kirikkale
Turkey Kocaeli University Faculty of Medicine Kocaeli
Turkey Kocaeli University Medical Faculty Kocaeli
Turkey Necmettin Erbakan University Meram Medical Faculty Konya
Turkey Ondokuz Mayis University Medical Faculty Samsun
Turkey Karadeniz Technical University Medical Faculty Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Turkish Thoracic Society

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. Erratum in: Am J Respir Crit Care Med2002 Aug 1;166(3):426. — View 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, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 years
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