Japanese Idiopathic Interstitial Pneumonias Registry
- Conditions
- Idiopathic Interstitial Pneumonia
- Registration Number
- NCT03041623
- Lead Sponsor
- North East Japan Study Group
- Brief 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.
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 867
- Patients aged between 20 and 84 years
- Patients with idiopathic pulmonary fibrosis (IPF) and other IIPs diagnosis within 6 months before registration at each facility
- Patients from whom written informed consent has been obtained regarding participation in this study and follow-up observation
- Patients for whom the tests (such as the lung function test) conducted in this study could not be performed
- Patients who underwent pulmonary resection
- Patients undergoing dialysis
- Patients with cancer treated at the time of registration or those planning to receive treatment in the future
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Data on current practice patterns for diagnosis of IIPs 3-4 years Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.
Prevalence of each categorized IIPs 3-4 years Investigate the prevalence of each categorized IIPs by using a recent guideline
Natural history of each categorized IIPs 3-4 years Describe the natural history of each categorized IIPs, focusing on CT findings, FVC changes, medications, and causes of death.
- Secondary Outcome Measures
Name Time Method Hospital admission for acute exacerbations of IIPs 3-6 years To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs
Quantitative evaluation of CT findings 3-6 years Validation of second multidisciplinary discussion 3-4 years 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.
Progression-free survival by category of IIPs 3-6 years Mean change of patient-reported outcome (Saint George Respiratory Questionnaire, COPD assessment test, and Dyspnoea-12) every12 months from baseline 3-4 years Validation of new guideline 3-6 years If there are changes in IIPs diagnostic guidelines or severity classification during this study, these changes will be verified.
Diagnosis of IIPs in patients with IIPs at registration At registration and 1 year after registration Describe the frequency of IIPs diagnosis using data at the time of registration.
Trial Locations
- Locations (86)
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Haruhi Respiratory Medical Hospital
🇯🇵Kiyosu, Aichi, Japan
Hirosaki University Hospital
🇯🇵Hirosaki, Aomori, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Ehime, Japan
Tottori University Hospital
🇯🇵Yonago, Tottori, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Kyushu University Hospital.
🇯🇵Fukuoka, Japan
University of Fukui Hospital
🇯🇵Yoshida, Fukui, Japan
St. Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Kochi medical School Hospital
🇯🇵Nankoku, Kochi, Japan
National Hospital Organization Tokyo National Hospital
🇯🇵Kiyose, Tokyo, Japan
Kinki University Hospital
🇯🇵Osakasayama, Osaka, Japan
Dokkyo Medical University Hospital
🇯🇵Tochigi, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Tokyo Medical and Dental University
🇯🇵Tokyo, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Toranomon Hospital
🇯🇵Tokyo, Japan
The Jikei University Hospital
🇯🇵Tokyo, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Tokyo, Japan
National Center for Global Health and Medicine
🇯🇵Tokyo, Japan
Teikyo University Hospital
🇯🇵Tokyo, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Tosei General Hospital
🇯🇵Seto, Aichi, Japan
Kameda Medical Center
🇯🇵Kamogawa, Chiba, Japan
Fukuoka University Chikushi Hospital
🇯🇵Chikushino, Fukuoka, Japan
Aso Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki, Gifu, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Iwate Prefectural Central Hospital
🇯🇵Morioka, Iwate, Japan
Kobe City Medical Center West Hospital
🇯🇵Kobe, Hyogo, Japan
Ibarakihigashi National Hospital
🇯🇵Naka, Ibaraki, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Showa University Fujigaoka Hospital
🇯🇵Yokohama, Kanagawa, Japan
Matsuzaka City Hospital
🇯🇵Matsuzaka, Mie, Japan
Japanese Red Cross Ise Hospital
🇯🇵Ise, Mie, Japan
Sendai Kousei Hospital
🇯🇵Sendai, Miyagi, Japan
Okinawa Chubu Hospital
🇯🇵Uruma, Okinawa, Japan
Saku Central Hospital Advanced Care Center
🇯🇵Saku, Nagano, Japan
Tenri Hospital
🇯🇵Tenri, Nara, Japan
Dokkyo Medical University Koshigaya Hospital
🇯🇵Koshigaya, Saitama, Japan
Shimane University Hospital
🇯🇵Izumo, Shimane, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
National Hospital Organization Yamaguchi-Ube Medical Center
🇯🇵Ube, Yamaguchi, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
National Hospital Organization Chiba-East-Hospital
🇯🇵Chiba, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto, Japan
National Hospital Organization Minami-Okayama Medical Center
🇯🇵Okayama, Japan
Japanese Red Cross Saitama Hospital
🇯🇵Saitama, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Japan
Tokyo University Hospital
🇯🇵Tokyo, Japan
NTT Medical Center Tokyo
🇯🇵Tokyo, Japan
Toho University Omori Medical Center
🇯🇵Tokyo, Japan
Japanese Red Cross Medical Center
🇯🇵Tokyo, Japan
JR Tokyo General Hospital
🇯🇵Tokyo, Japan
Nihon University Itabashi Hospital
🇯🇵Tokyo, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Yamagata City Hospital Saiseikan
🇯🇵Yamagata, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki, Okayama, Japan
National Hospital Organization Kinki-chuo Chest Medical Center
🇯🇵Sakai, Osaka, Japan
Fujita Health University Hospital
🇯🇵Toyoake, Aichi, Japan
Tohoku Medical and Pharmaceutical University Hospital
🇯🇵Sendai, Miyagi, Japan
Suwa Central Hospital
🇯🇵Chino, Nagano, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Nagano, Japan
National Hospital Organization Matsue Medical Center
🇯🇵Matsue, Shimane, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
National Hospital Organization Himeji Medical Center
🇯🇵Himeji, Hyogo, Japan
University of Occupational and Environmental Health Japan
🇯🇵Kitakyushu, Hukuoka, Japan
Hamamatsu Rosai Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Shiga University of Medical Science Hospital
🇯🇵Otsu, Shiga, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Yokohama, Kanagawa, Japan
Jichi Medical University
🇯🇵Shimotsuke, Tochigi, Japan
Seirei Mikatahara General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima, Japan
Kyorin University Hospital
🇯🇵Mitaka, Tokyo, Japan