Japanese Idiopathic Interstitial Pneumonias Registry

NCT ID: NCT03041623

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

867 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Idiopathic Interstitial Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

North East Japan Study Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Takashi Ogura, MD

Role: PRINCIPAL_INVESTIGATOR

Kanagawa Cardiovascular and Respiratory Center

Locations

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Haruhi Respiratory Medical Hospital

Kiyosu, Aichi-ken, Japan

Site Status

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Tosei General Hospital

Seto, Aichi-ken, Japan

Site Status

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Site Status

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Site Status

Kameda Medical Center

Kamogawa, Chiba, Japan

Site Status

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

Site Status

University of Fukui Hospital

Yoshida, Fukui, Japan

Site Status

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Site Status

Aso Iizuka Hospital

Iizuka, Fukuoka, Japan

Site Status

Kurume University Hospital

Kurume, Fukuoka, Japan

Site Status

Ogaki Municipal Hospital

Ōgaki, Gifu, Japan

Site Status

Gunma University Hospital

Maebashi, Gunma, Japan

Site Status

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Site Status

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Site Status

University of Occupational and Environmental Health Japan

Kitakyushu, Hukuoka, Japan

Site Status

National Hospital Organization Himeji Medical Center

Himeji, Hyōgo, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

Kobe City Medical Center West Hospital

Kobe, Hyōgo, Japan

Site Status

Ibarakihigashi National Hospital

Naka, Ibaraki, Japan

Site Status

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Site Status

Iwate Prefectural Central Hospital

Morioka, Iwate, Japan

Site Status

Tokai University Hospital

Isehara, Kanagawa, Japan

Site Status

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Site Status

Showa University Fujigaoka Hospital

Yokohama, Kanagawa, Japan

Site Status

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, Japan

Site Status

Kochi medical School Hospital

Nankoku, Kochi, Japan

Site Status

Japanese Red Cross Ise Hospital

Ise, Mie-ken, Japan

Site Status

Matsuzaka City Hospital

Matsuzaka, Mie-ken, Japan

Site Status

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Site Status

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, Japan

Site Status

Suwa Central Hospital

Chino, Nagano, Japan

Site Status

Shinshu University Hospital

Matsumoto, Nagano, Japan

Site Status

Saku Central Hospital Advanced Care Center

Saku, Nagano, Japan

Site Status

Tenri Hospital

Tenri, Nara, Japan

Site Status

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Site Status

Okinawa Chubu Hospital

Uruma, Okinawa, Japan

Site Status

National Hospital Organization Kinki-chuo Chest Medical Center

Sakai, Osaka, Japan

Site Status

Kinki University Hospital

Sayama, Osaka, Japan

Site Status

Dokkyo Medical University Koshigaya Hospital

Koshigaya, Saitama, Japan

Site Status

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Site Status

Shimane University Hospital

Izumo, Shimane, Japan

Site Status

National Hospital Organization Matsue Medical Center

Matsue, Shimane, Japan

Site Status

Hamamatsu Rosai Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Seirei Mikatahara General Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Jichi Medical University

Shimotsuke, Tochigi, Japan

Site Status

National Hospital Organization Tokyo National Hospital

Kiyose, Tokyo, Japan

Site Status

Kyorin University Hospital

Mitaka, Tokyo, Japan

Site Status

Tottori University Hospital

Yonago, Tottori, Japan

Site Status

National Hospital Organization Yamaguchi-Ube Medical Center

Ube, Yamaguchi, Japan

Site Status

Chiba University Hospital

Chiba, , Japan

Site Status

National Hospital Organization Chiba-East-Hospital

Chiba, , Japan

Site Status

Kyushu University Hospital.

Fukuoka, , Japan

Site Status

Fukuoka University Hospital

Fukuoka, , Japan

Site Status

Fukushima Medical University Hospital

Fukushima, , Japan

Site Status

Hiroshima Prefectural Hospital

Hiroshima, , Japan

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

Kagoshima University Hospital

Kagoshima, , Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

Saiseikai Kumamoto Hospital

Kumamoto, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Nagasaki University Hospital

Nagasaki, , Japan

Site Status

Niigata University Medical and Dental Hospital

Niigata, , Japan

Site Status

National Hospital Organization Minami-Okayama Medical Center

Okayama, , Japan

Site Status

Japanese Red Cross Saitama Hospital

Saitama, , Japan

Site Status

Dokkyo Medical University Hospital

Tochigi, , Japan

Site Status

Tokushima University Hospital

Tokushima, , Japan

Site Status

Toranomon Hospital

Tokyo, , Japan

Site Status

The Jikei University Hospital

Tokyo, , Japan

Site Status

Juntendo University Hospital

Tokyo, , Japan

Site Status

Tokyo Medical and Dental University

Tokyo, , Japan

Site Status

Nippon Medical School Hospital

Tokyo, , Japan

Site Status

Tokyo University Hospital

Tokyo, , Japan

Site Status

NTT Medical Center Tokyo

Tokyo, , Japan

Site Status

Toho University Omori Medical Center

Tokyo, , Japan

Site Status

Japanese Red Cross Medical Center

Tokyo, , Japan

Site Status

JR Tokyo General Hospital

Tokyo, , Japan

Site Status

National Hospital Organization Tokyo Medical Center

Tokyo, , Japan

Site Status

National Center for Global Health and Medicine

Tokyo, , Japan

Site Status

Teikyo University Hospital

Tokyo, , Japan

Site Status

Nihon University Itabashi Hospital

Tokyo, , Japan

Site Status

Toyama University Hospital

Toyama, , Japan

Site Status

Yamagata City Hospital Saiseikan

Yamagata, , Japan

Site Status

Countries

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Japan

References

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Okuda R, Ogura T, Hisata S, Baba T, Kondoh Y, Suda T, Johkoh T, Iwasawa T, Tomioka H, Bando M, Azuma A, Inoue Y, Ishikawa N, Arai N, Takihara T, Hamaguchi M, Arai T, Nakamura Y, Miyamoto A, Tomii K, Miyazaki Y, Chiba H, Ishii H, Hamada N, Terasaki Y, Fukuoka J, Sakai F, Egashira R, Fujimoto K, Sumikawa H, Suzuki T, Sakamoto S, Nishioka Y, Hattori N, Hashimoto N, Morita S, Ichihara N, Miyata H, Hagiwara K, Kobayashi K, Nukiwa T; JIPS registry collaborators. Prognostic prediction for newly diagnosed patients with idiopathic interstitial pneumonia: JIPS Registry (NEJ030). Respir Investig. 2025 May;63(3):365-372. doi: 10.1016/j.resinv.2025.02.009. Epub 2025 Mar 17.

Reference Type DERIVED
PMID: 40101437 (View on PubMed)

Okuda R, Ogura T, Hisata S, Baba T, Kondoh Y, Suda T, Johkoh T, Iwasawa T, Tomioka H, Bando M, Azuma A, Inoue Y, Arai T, Nakamura Y, Miyamoto A, Miyazaki Y, Chiba H, Ishii H, Hamada N, Terasaki Y, Kuwahira I, Sato S, Kato S, Suzuki T, Sakamoto S, Nishioka Y, Hattori N, Hashimoto N, Morita S, Ichihara N, Miyata H, Hagiwara K, Nukiwa T, Kobayashi K. Design and rationale of the Japanese Idiopathic Interstitial Pneumonias (JIPS) Registry. Respir Investig. 2023 Jan;61(1):95-102. doi: 10.1016/j.resinv.2022.08.009. Epub 2022 Nov 15.

Reference Type DERIVED
PMID: 36580379 (View on PubMed)

Other Identifiers

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NEJ030

Identifier Type: -

Identifier Source: org_study_id

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