- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02821039
Turkish Thoracic Society Usual Interstitial Pneumonia Registry Study (TURK-UIP)
23. september 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1678
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Adana, Kalkun
- Cukurova University Medical Faculty
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Adapazari, Kalkun
- Sakarya University Faculty of Medicine
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Ankara, Kalkun, MD
- Gazi University Medical Faculty
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Ankara, Kalkun
- Ankara University Faculty of Medicine
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Ankara, Kalkun
- Ankara University Medical Faculty
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Ankara, Kalkun
- Ataturk Chest Diseases and Chest Surgery Education and Research Hospital
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Ankara, Kalkun
- Atatürk Chest Disease and Chest Surgery Research and Training Hospital
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Ankara, Kalkun
- Dışkapı Yıldırım Beyazıt training and research hospital
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Ankara, Kalkun
- Gazi University Medical Faculty
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Antalya, Kalkun
- Akdeniz University Medical Faculty
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Aydin, Kalkun
- Adnan Menderes University Faculty of Medicine
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Bursa, Kalkun
- Uludag University Medical Faculty
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Denizli, Kalkun
- Pamukkale University Medical Faculty
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Diyarbakir, Kalkun
- Dicle University Medical Faculty
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Diyarbakir, Kalkun
- Memorial Diyarbakir Hospital
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Duzce, Kalkun
- Duzce University Medical Faculty
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Edirne, Kalkun
- Trakya University Faculty of Medicine
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Erzurum, Kalkun
- Ataturk University Faculty of Medicine
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Erzurum, Kalkun
- Ataturk University Medical Faculty
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Istanbul, Kalkun
- Dr.Lutfi Kirdar Kartal Education and Research Hospital
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Istanbul, Kalkun
- Istanbul University Cerrahpasa Medical Faculty
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Istanbul, Kalkun
- Istanbul University Istanbul Medical Faculty
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Istanbul, Kalkun
- Istanbul University, Istanbul Medical Faculty
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Istanbul, Kalkun
- Koç University Medical Faculty
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Istanbul, Kalkun
- Sisli Florence Nightingale Hospital
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Istanbul, Kalkun
- Sureyyapasa Chest Diseases and Thoracic Surgery Education and Research Hospital
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Istanbul, Kalkun
- Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
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Istanbul, Kalkun
- Süreyyapasa Pulmonary Diseases and Thoracic Surgery Education and Research Hospital
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Istanbul, Kalkun
- Yedikule Chest Disease Education and Research Hospital
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Istanbul, Kalkun
- Yedikule Chest Diseases and Chest Surgery Education and Research Hospital
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Istanbul, Kalkun
- Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital
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Istanbul, Kalkun
- Yedikule Chest Diseases Education and Research Hospital
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Istanbul, Kalkun
- Yedikule Hospital for Chest Disease and Chest Surgery
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Istanbul, Kalkun
- Yedikule Hospital for Chest Disease and Thoracic Surgery
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Istanbul, Kalkun
- Yedikule Pulmonary Diseases Education and Research Hospital
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Izmir, Kalkun
- Dokuz Eylul University Medical Faculty
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Izmir, Kalkun
- Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital
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Izmir, Kalkun
- Dr. Suat Seren Pulmonary Diseases and Thoracic Surgery Training and Research Hospital
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Izmir, Kalkun
- Ege University Faculty of Medicine
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Izmir, Kalkun
- Ege University Medical Faculty
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Kirikkale, Kalkun
- Kirikkale University Medical Faculty
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Kocaeli, Kalkun
- Kocaeli University Faculty of Medicine
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Kocaeli, Kalkun
- Kocaeli University Medical Faculty
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Konya, Kalkun
- Necmettin Erbakan University Meram Medical Faculty
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Samsun, Kalkun
- Ondokuz Mayis University Medical Faculty
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Trabzon, Kalkun
- Karadeniz Technical University Medical Faculty
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects diagnosed with IPF and other causes of UIP.
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of subjects enrolled with IPF and other causes of UIP
Tidsramme: 5 years
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Natural history of course of disease in patients with IPF and other causes of UIP.
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5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Benan Müsellim, MD, Istanbul University,Cerrahpasa Medical Faculty, Istanbul, Turkey.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2016
Primær færdiggørelse (Faktiske)
8. juli 2019
Studieafslutning (Faktiske)
8. juli 2019
Datoer for studieregistrering
Først indsendt
29. juni 2016
Først indsendt, der opfyldte QC-kriterier
30. juni 2016
Først opslået (Skøn)
1. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TTS-01
Plan for individuelle deltagerdata (IPD)
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .