Japanese Idiopathic Interstitial Pneumonias Registry

Idiopathic Interstitial Pneumonia Clinical Trial

— JIPS  

Official title:

Japanese Idiopathic Interstitial Pneumonias Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03041623
• Other study ID #: NEJ030
• Status: Active, not recruiting
• Start date: December 2016
• Est. completion date: May 2023

Study information

• Verified date: March 2021
• Source: North East Japan Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

An objective of JIPS Registry is to examine disease behavior of idiopathic interstitial pneumonias (IIPs), considering classification, background, and diagnostic methods based on American Thoracic Society (ATS)/ European Respiratory Society(ERS) /Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) guidelines for diagnosis and the ATS/ERS classification of 2002 and 2013.

Description:

JIPS Registry is a multi-site, non-interventional, prospective observation study of patients with newly diagnosed IIPs in Japan. At least 600 patients will be registered for 16 months at approximately 80 sites in Japan. Primary research question is to determine the natural history of each category of IIPs at registration, patient background and diagnosis methods will be considered. Furthermore, the present treatment patterns and disease behavior (CT and forced vital capacity (FVC) changes, as well as changes in interstitial pneumonia markers, etc.) will also be investigated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 867
• Est. completion date: May 2023
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

Inclusion Criteria:

1. Patients aged between 20 and 84 years

2. Patients with idiopathic pulmonary fibrosis (IPF) and other IIPs diagnosis within 6 months before registration at each facility

3. Patients from whom written informed consent has been obtained regarding participation in this study and follow-up observation

Exclusion Criteria:

1. Patients for whom the tests (such as the lung function test) conducted in this study could not be performed

2. Patients who underwent pulmonary resection

3. Patients undergoing dialysis

4. Patients with cancer treated at the time of registration or those planning to receive treatment in the future

Related Conditions & MeSH terms

• Idiopathic Interstitial Pneumonia
• Idiopathic Interstitial Pneumonias
• Lung Diseases, Interstitial
• Pneumonia
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Japan	Asahikawa Medical University Hospital	Asahikawa	Hokkaido
Japan	Chiba University Hospital	Chiba
Japan	National Hospital Organization Chiba-East-Hospital	Chiba
Japan	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka
Japan	Suwa Central Hospital	Chino	Nagano
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kyushu University Hospital.	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hamamatsu Rosai Hospital	Hamamatsu	Shizuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	Seirei Mikatahara General Hospital	Hamamatsu	Shizuoka
Japan	National Hospital Organization Himeji Medical Center	Himeji	Hyogo
Japan	Hirosaki University Hospital	Hirosaki	Aomori
Japan	Hiroshima Prefectural Hospital	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Aso Iizuka Hospital	Iizuka	Fukuoka
Japan	Japanese Red Cross Ise Hospital	Ise	Mie
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kameda Medical Center	Kamogawa	Chiba
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa
Japan	University of Occupational and Environmental Health Japan	Kitakyushu	Hukuoka
Japan	National Hospital Organization Tokyo National Hospital	Kiyose	Tokyo
Japan	Haruhi Respiratory Medical Hospital	Kiyosu	Aichi
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Kobe City Medical Center West Hospital	Kobe	Hyogo
Japan	Dokkyo Medical University Koshigaya Hospital	Koshigaya	Saitama
Japan	Kumamoto University Hospital	Kumamoto
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	National Hospital Organization Matsue Medical Center	Matsue	Shimane
Japan	Shinshu University Hospital	Matsumoto	Nagano
Japan	Ehime Prefectural Central Hospital	Matsuyama	Ehime
Japan	Matsuzaka City Hospital	Matsuzaka	Mie
Japan	Kyorin University Hospital	Mitaka	Tokyo
Japan	Iwate Prefectural Central Hospital	Morioka	Iwate
Japan	Nagasaki University Hospital	Nagasaki
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Ibarakihigashi National Hospital	Naka	Ibaraki
Japan	Kochi medical School Hospital	Nankoku	Kochi
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Ogaki Municipal Hospital	Ogaki	Gifu
Japan	National Hospital Organization Minami-Okayama Medical Center	Okayama
Japan	Kinki University Hospital	Osakasayama	Osaka
Japan	Shiga University of Medical Science Hospital	Otsu	Shiga
Japan	Japanese Red Cross Saitama Hospital	Saitama
Japan	National Hospital Organization Kinki-chuo Chest Medical Center	Sakai	Osaka
Japan	Saku Central Hospital Advanced Care Center	Saku	Nagano
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	Tohoku Medical and Pharmaceutical University Hospital	Sendai	Miyagi
Japan	Tosei General Hospital	Seto	Aichi
Japan	Jichi Medical University	Shimotsuke	Tochigi
Japan	Tenri Hospital	Tenri	Nara
Japan	Dokkyo Medical University Hospital	Tochigi
Japan	Tokushima University Hospital	Tokushima
Japan	Japanese Red Cross Medical Center	Tokyo
Japan	JR Tokyo General Hospital	Tokyo
Japan	Juntendo University Hospital	Tokyo
Japan	National Center for Global Health and Medicine	Tokyo
Japan	National Hospital Organization Tokyo Medical Center	Tokyo
Japan	Nihon University Itabashi Hospital	Tokyo
Japan	Nippon Medical School Hospital	Tokyo
Japan	NTT Medical Center Tokyo	Tokyo
Japan	Teikyo University Hospital	Tokyo
Japan	The Jikei University Hospital	Tokyo
Japan	Toho University Omori Medical Center	Tokyo
Japan	Tokyo Medical and Dental University	Tokyo
Japan	Tokyo University Hospital	Tokyo
Japan	Toranomon Hospital	Tokyo
Japan	Toyama University Hospital	Toyama
Japan	Fujita Health University Hospital	Toyoake	Aichi
Japan	National Hospital Organization Yamaguchi-Ube Medical Center	Ube	Yamaguchi
Japan	Okinawa Chubu Hospital	Uruma	Okinawa
Japan	Yamagata City Hospital Saiseikan	Yamagata
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama	Kanagawa
Japan	Showa University Fujigaoka Hospital	Yokohama	Kanagawa
Japan	Tottori University Hospital	Yonago	Tottori
Japan	University of Fukui Hospital	Yoshida	Fukui

Sponsors (2)

Lead Sponsor	Collaborator
North East Japan Study Group	Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data on current practice patterns for diagnosis of IIPs	Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.	3-4 years
Primary	Prevalence of each categorized IIPs	Investigate the prevalence of each categorized IIPs by using a recent guideline	3-4 years
Primary	Natural history of each categorized IIPs	Describe the natural history of each categorized IIPs, focusing on CT findings, FVC changes, medications, and causes of death.	3-4 years
Secondary	Progression-free survival by category of IIPs		3-6 years
Secondary	Hospital admission for acute exacerbations of IIPs	To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs	3-6 years
Secondary	Mean change of patient-reported outcome (Saint George Respiratory Questionnaire, COPD assessment test, and Dyspnoea-12) every12 months from baseline		3-4 years
Secondary	Quantitative evaluation of CT findings		3-6 years
Secondary	Validation of second multidisciplinary discussion	Multidisciplinary discussion (MDD) held by independent central reviewers will be conducted twice at the time of registration and final observation using questionnaire. Concordance rate for diagnosis and disease behavior in each case between the time of registration and final observation will be evaluated.	3-4 years
Secondary	Validation of new guideline	If there are changes in IIPs diagnostic guidelines or severity classification during this study, these changes will be verified.	3-6 years
Secondary	Diagnosis of IIPs in patients with IIPs at registration	Describe the frequency of IIPs diagnosis using data at the time of registration.	At registration and 1 year after registration