Clinical trial NCT03041623: Japanese Idiopathic Interstitial Pneumonias Registry
Official title: Japanese Idiopathic Interstitial Pneumonias Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Idiopathic Interstitial Pneumonia
Keywords: IIPs
Lead sponsor: North East Japan Study Group
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2017-02-03
Enrollment: 867
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed IIPs within 6 months before registration

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.

Eligibility criteria: 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

Primary outcomes:
measure: Data on current practice patterns for diagnosis of IIPs
timeFrame: 3-4 years
measure: Prevalence of each categorized IIPs
timeFrame: 3-4 years
measure: Natural history of each categorized IIPs
timeFrame: 3-4 years
Secondary outcomes:
measure: Progression-free survival by category of IIPs
timeFrame: 3-6 years
measure: Hospital admission for acute exacerbations of IIPs
timeFrame: 3-6 years
measure: Mean change of patient-reported outcome (Saint George Respiratory Questionnaire, COPD assessment test, and Dyspnoea-12) every12 months from baseline
timeFrame: 3-4 years
measure: Quantitative evaluation of CT findings
timeFrame: 3-6 years
measure: Validation of second multidisciplinary discussion
timeFrame: 3-4 years
measure: Validation of new guideline
timeFrame: 3-6 years
measure: Diagnosis of IIPs in patients with IIPs at registration
timeFrame: At registration and 1 year after registration
Other outcomes:
Locations:
city: Kiyosu
country: Japan
facility: Haruhi Respiratory Medical Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Seto
country: Japan
facility: Tosei General Hospital
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Kamogawa
country: Japan
facility: Kameda Medical Center
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime
city: Yoshida
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Iizuka
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Kitakyushu
country: Japan
facility: University of Occupational and Environmental Health Japan
state: Hukuoka
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center West Hospital
state: Hyogo
city: Naka
country: Japan
facility: Ibarakihigashi National Hospital
state: Ibaraki
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Prefectural Central Hospital
state: Iwate
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Showa University Fujigaoka Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
state: Kanagawa
city: Nankoku
country: Japan
facility: Kochi medical School Hospital
state: Kochi
city: Ise
country: Japan
facility: Japanese Red Cross Ise Hospital
state: Mie
city: Matsuzaka
country: Japan
facility: Matsuzaka City Hospital
state: Mie
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku Medical and Pharmaceutical University Hospital
state: Miyagi
city: Chino
country: Japan
facility: Suwa Central Hospital
state: Nagano
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Saku
country: Japan
facility: Saku Central Hospital Advanced Care Center
state: Nagano
city: Tenri
country: Japan
facility: Tenri Hospital
state: Nara
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Uruma
country: Japan
facility: Okinawa Chubu Hospital
state: Okinawa
city: Osakasayama
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center
state: Osaka
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Koshigaya Hospital
state: Saitama
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Matsue
country: Japan
facility: National Hospital Organization Matsue Medical Center
state: Shimane
city: Hamamatsu
country: Japan
facility: Hamamatsu Rosai Hospital
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Seirei Mikatahara General Hospital
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University
state: Tochigi
city: Kiyose
country: Japan
facility: National Hospital Organization Tokyo National Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Ube
country: Japan
facility: National Hospital Organization Yamaguchi-Ube Medical Center
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: National Hospital Organization Chiba-East-Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital.
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Minami-Okayama Medical Center
city: Saitama
country: Japan
facility: Japanese Red Cross Saitama Hospital
city: Tochigi
country: Japan
facility: Dokkyo Medical University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Tokyo University Hospital
city: Tokyo
country: Japan
facility: NTT Medical Center Tokyo
city: Tokyo
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Tokyo
country: Japan
facility: JR Tokyo General Hospital
city: Tokyo
country: Japan
facility: National Hospital Organization Tokyo Medical Center
city: Tokyo
country: Japan
facility: National Center for Global Health and Medicine
city: Tokyo
country: Japan
facility: Teikyo University Hospital
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Yamagata
country: Japan
facility: Yamagata City Hospital Saiseikan
Study officials:
affiliation: Kanagawa Cardiovascular and Respiratory Center
name: Takashi Ogura, MD
role: PRINCIPAL_INVESTIGATOR
References: