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Idiopathic Interstitial PneumoniaJIPSNCT03041623

Japanese Idiopathic Interstitial Pneumonias Registry

An observational study of Idiopathic Interstitial Pneumonia, run by North East Japan Study Group at 86 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 84 years
Conditions the study is for
Idiopathic Interstitial Pneumonia
How many people
867 participants
Where
86 sitesJapan
Study dates
Dec 2016to Mar 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Newly diagnosed IIPs within 6 months before registration

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

Japan86 sites

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido, 078-8510

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • National Hospital Organization Chiba-East-Hospital

    Chiba, Chiba, 260-8712

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, 818-8502

  • Suwa Central Hospital

    Chino, Nagano, 391-8503

  • Kyushu University Hospital.

    Fukuoka, Fukuoka, 812-8582

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Hamamatsu Rosai Hospital

    Hamamatsu, Shizuoka, 430-8525

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3126

  • Seirei Mikatahara General Hospital

    Hamamatsu, Shizuoka, 433-8558

  • National Hospital Organization Himeji Medical Center

    Himeji, Hyōgo, 670-8520

  • Hirosaki University Hospital

    Hirosaki, Aomori, 036-8562

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 734-8530

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Aso Iizuka Hospital

    Iizuka, Fukuoka, 820-8505

  • Japanese Red Cross Ise Hospital

    Ise, Mie-ken, 516-8512

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193

  • Shimane University Hospital

    Izumo, Shimane, 693-8501

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

  • Kameda Medical Center

    Kamogawa, Chiba, 296-8602

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511

  • University of Occupational and Environmental Health Japan

    Kitakyushu, Hukuoka, 807-8555

  • National Hospital Organization Tokyo National Hospital

    Kiyose, Tokyo, 204-8585

  • Haruhi Respiratory Medical Hospital

    Kiyosu, Aichi-ken, 452-0962

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kobe City Medical Center West Hospital

    Kobe, Hyōgo, 653-0013

  • Dokkyo Medical University Koshigaya Hospital

    Koshigaya, Saitama, 343-8555

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4193

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • National Hospital Organization Matsue Medical Center

    Matsue, Shimane, 690-8556

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime, 790-0024

  • Matsuzaka City Hospital

    Matsuzaka, Mie-ken, 515-8544

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • Iwate Prefectural Central Hospital

    Morioka, Iwate, 020-0066

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8510

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8601

  • Ibarakihigashi National Hospital

    Naka, Ibaraki, 319-1113

  • Kochi medical School Hospital

    Nankoku, Kochi, 783-8505

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8510

  • Ogaki Municipal Hospital

    Ōgaki, Gifu, 503-8502

  • National Hospital Organization Minami-Okayama Medical Center

    Okayama, Okayama-ken, 701-0304

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Japanese Red Cross Saitama Hospital

    Saitama, Saitama, 330-8553

  • National Hospital Organization Kinki-chuo Chest Medical Center

    Sakai, Osaka, 591-8555

  • Saku Central Hospital Advanced Care Center

    Saku, Nagano, 385-0051

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • Kinki University Hospital

    Sayama, Osaka, 589-8511

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, Miyagi, 983-8512

  • Tosei General Hospital

    Seto, Aichi-ken, 489-8642

  • Jichi Medical University

    Shimotsuke, Tochigi, 329-0498

  • Tenri Hospital

    Tenri, Nara, 632-8552

  • Dokkyo Medical University Hospital

    Tochigi, Tochigi, 321-0293

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8053

  • Toranomon Hospital

    Tokyo, Tokyo, 105-8470

  • The Jikei University Hospital

    Tokyo, Tokyo, 105-8471

  • Juntendo University Hospital

    Tokyo, Tokyo, 113-8431

  • Tokyo Medical and Dental University

    Tokyo, Tokyo, 113-8519

  • Nippon Medical School Hospital

    Tokyo, Tokyo, 113-8603

  • Tokyo University Hospital

    Tokyo, Tokyo, 113-8655

  • NTT Medical Center Tokyo

    Tokyo, Tokyo, 141-8625

  • Toho University Omori Medical Center

    Tokyo, Tokyo, 143-8541

  • Japanese Red Cross Medical Center

    Tokyo, Tokyo, 150-8935

  • JR Tokyo General Hospital

    Tokyo, Tokyo, 151-8528

  • National Hospital Organization Tokyo Medical Center

    Tokyo, Tokyo, 152-8902

  • National Center for Global Health and Medicine

    Tokyo, Tokyo, 162-8655

  • Teikyo University Hospital

    Tokyo, Tokyo, 173-8605

  • Nihon University Itabashi Hospital

    Tokyo, Tokyo, 173-8610

  • Toyama University Hospital

    Toyama, Toyama, 930-0194

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192

  • National Hospital Organization Yamaguchi-Ube Medical Center

    Ube, Yamaguchi, 755-0241

  • Okinawa Chubu Hospital

    Uruma, Okinawa, 904-2293

  • Yamagata City Hospital Saiseikan

    Yamagata, Yamagata, 990-8533

  • Showa University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8501

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051

  • Tottori University Hospital

    Yonago, Tottori, 683-0853

  • University of Fukui Hospital

    Yoshida, Fukui, 910-1193

Other trials in Japan

About this study

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.

Read the 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.

Keywords
IIPs
Medical subject headings
Idiopathic Interstitial Pneumonias

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Data on current practice patterns for diagnosis of IIPs

    Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.

    Measured: 3-4 years

  2. Prevalence of each categorized IIPs

    Investigate the prevalence of each categorized IIPs by using a recent guideline

    Measured: 3-4 years

  3. 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.

    Measured: 3-4 years

Secondary outcomes (7)

  1. Progression-free survival by category of IIPs

    Measured: 3-6 years

  2. Hospital admission for acute exacerbations of IIPs

    To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs

    Measured: 3-6 years

  3. Mean change of patient-reported outcome (Saint George Respiratory Questionnaire, COPD assessment test, and Dyspnoea-12) every12 months from baseline

    Measured: 3-4 years

  4. Quantitative evaluation of CT findings

    Measured: 3-6 years

  5. 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.

    Measured: 3-4 years

  6. Validation of new guideline

    If there are changes in IIPs diagnostic guidelines or severity classification during this study, these changes will be verified.

    Measured: 3-6 years

  7. Diagnosis of IIPs in patients with IIPs at registration

    Describe the frequency of IIPs diagnosis using data at the time of registration.

    Measured: At registration and 1 year after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionSep 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
867 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03041623
Sponsor's protocol ID
NEJ030
Acronym
JIPS
Status last verified
Feb 2026
First submitted
18 Dec 2016
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40101437

  • 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.

    PubMed 36580379

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Interstitial Pneumonia, run by North East Japan Study Group at 86 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Data on current practice patterns for diagnosis of IIPs (time frame: 3-4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041623, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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