- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03041623
Japanese Idiopathic Interstitial Pneumonias Registry (JIPS)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chiba, Japan, 260-8677
- Chiba University Hospital
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Chiba, Japan, 260-8712
- National Hospital Organization Chiba-East-Hospital
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Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital.
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Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hiroshima, Japan, 734-8530
- Hiroshima Prefectural Hospital
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Kagoshima, Japan, 890-8520
- Kagoshima University Hospital
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Kumamoto, Japan, 861-4193
- Saiseikai Kumamoto Hospital
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Kumamoto, Japan, 860-8556
- Kumamoto University Hospital
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Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Nagasaki, Japan, 852-8510
- Nagasaki University Hospital
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Niigata, Japan, 951-8510
- Niigata University Medical and Dental Hospital
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Okayama, Japan, 701-0304
- National Hospital Organization Minami-Okayama Medical Center
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Saitama, Japan, 330-8553
- Japanese Red Cross Saitama Hospital
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Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
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Tokushima, Japan, 770-8053
- Tokushima University Hospital
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Tokyo, Japan, 143-8541
- Toho University Omori Medical Center
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Tokyo, Japan, 105-8470
- Toranomon Hospital
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Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Tokyo, Japan, 141-8625
- NTT Medical Center Tokyo
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Tokyo, Japan, 105-8471
- The Jikei University Hospital
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Tokyo, Japan, 113-8519
- Tokyo Medical and Dental University
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Tokyo, Japan, 152-8902
- National Hospital Organization Tokyo Medical Center
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Tokyo, Japan, 173-8610
- Nihon University Itabashi Hospital
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Tokyo, Japan, 113-8603
- Nippon Medical School Hospital
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Tokyo, Japan, 162-8655
- National Center for Global Health and Medicine
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Tokyo, Japan, 150-8935
- Japanese Red Cross Medical Center
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Tokyo, Japan, 151-8528
- JR Tokyo General Hospital
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Tokyo, Japan, 113-8655
- Tokyo University Hospital
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Tokyo, Japan, 173-8605
- Teikyo University Hospital
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Toyama, Japan, 930-0194
- Toyama University Hospital
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Yamagata, Japan, 990-8533
- Yamagata City Hospital Saiseikan
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Aichi
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Kiyosu, Aichi, Japan, 452-0962
- Haruhi Respiratory Medical Hospital
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Nagoya, Aichi, Japan, 466-8560
- Nagoya University Hospital
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Nagoya, Aichi, Japan, 467-8601
- Nagoya City University Hospital
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Seto, Aichi, Japan, 489-8642
- Tosei General Hospital
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Toyoake, Aichi, Japan, 470-1192
- Fujita Health University Hospital
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Aomori
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Hirosaki, Aomori, Japan, 036-8562
- Hirosaki University Hospital
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Chiba
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Kamogawa, Chiba, Japan, 296-8602
- Kameda Medical Center
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Ehime
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Matsuyama, Ehime, Japan, 790-0024
- Ehime Prefectural Central Hospital
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Fukui
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Yoshida, Fukui, Japan, 910-1193
- University of Fukui Hospital
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Fukuoka
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Chikushino, Fukuoka, Japan, 818-8502
- Fukuoka University Chikushi Hospital
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Iizuka, Fukuoka, Japan, 820-8505
- Aso Iizuka Hospital
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Kurume, Fukuoka, Japan, 830-0011
- Kurume University Hospital
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Gifu
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Ogaki, Gifu, Japan, 503-8502
- Ogaki Municipal Hospital
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Gunma
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Maebashi, Gunma, Japan, 371-8511
- Gunma University Hospital
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Hokkaido
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Asahikawa, Hokkaido, Japan, 078-8510
- Asahikawa Medical University Hospital
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Sapporo, Hokkaido, Japan, 060-8543
- Sapporo Medical University Hospital
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Hukuoka
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Kitakyushu, Hukuoka, Japan, 807-8555
- University of Occupational and Environmental Health Japan
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Hyogo
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Himeji, Hyogo, Japan, 670-8520
- National Hospital Organization Himeji Medical Center
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Kobe, Hyogo, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Kobe, Hyogo, Japan, 653-0013
- Kobe City Medical Center West Hospital
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Ibaraki
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Naka, Ibaraki, Japan, 319-1113
- Ibarakihigashi National Hospital
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Ishikawa
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Kanazawa, Ishikawa, Japan, 920-8641
- Kanazawa University Hospital
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Iwate
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Morioka, Iwate, Japan, 020-0066
- Iwate Prefectural Central Hospital
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Kanagawa
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Isehara, Kanagawa, Japan, 259-1193
- Tokai University Hospital
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Kawasaki, Kanagawa, Japan, 216-8511
- St. Marianna University School of Medicine Hospital
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Yokohama, Kanagawa, Japan, 227-8501
- Showa University Fujigaoka Hospital
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Yokohama, Kanagawa, Japan, 236-0051
- Kanagawa Cardiovascular and Respiratory Center
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Kochi
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Nankoku, Kochi, Japan, 783-8505
- Kochi Medical School Hospital
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Mie
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Ise, Mie, Japan, 516-8512
- Japanese Red Cross Ise Hospital
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Matsuzaka, Mie, Japan, 515-8544
- Matsuzaka City Hospital
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Miyagi
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Sendai, Miyagi, Japan, 980-0873
- Sendai Kousei Hospital
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Sendai, Miyagi, Japan, 983-8512
- Tohoku Medical and Pharmaceutical University Hospital
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Nagano
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Chino, Nagano, Japan, 391-8503
- Suwa Central Hospital
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Matsumoto, Nagano, Japan, 390-8621
- Shinshu University Hospital
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Saku, Nagano, Japan, 385-0051
- Saku Central Hospital Advanced Care Center
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Nara
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Tenri, Nara, Japan, 632-8552
- Tenri Hospital
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Okayama
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Kurashiki, Okayama, Japan, 710-8602
- Kurashiki Central Hospital
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Okinawa
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Uruma, Okinawa, Japan, 904-2293
- Okinawa Chubu Hospital
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Osaka
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Osakasayama, Osaka, Japan, 589-8511
- Kinki University Hospital
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Sakai, Osaka, Japan, 591-8555
- National Hospital Organization Kinki-Chuo Chest Medical Center
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Saitama
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Koshigaya, Saitama, Japan, 343-8555
- Dokkyo Medical University Koshigaya Hospital
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Shiga
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Otsu, Shiga, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Shimane
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Izumo, Shimane, Japan, 693-8501
- Shimane University Hospital
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Matsue, Shimane, Japan, 690-8556
- National Hospital Organization Matsue Medical Center
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 433-8558
- Seirei Mikatahara General Hospital
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Hamamatsu, Shizuoka, Japan, 430-8558
- Seirei Hamamatsu General Hospital
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Hamamatsu, Shizuoka, Japan, 430-8525
- Hamamatsu Rosai Hospital
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Hamamatsu, Shizuoka, Japan, 431-3126
- Hamamatsu University Hospital
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Tochigi
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Shimotsuke, Tochigi, Japan, 329-0498
- Jichi Medical University
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Tokyo
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Kiyose, Tokyo, Japan, 204-8585
- National Hospital Organization Tokyo National Hospital
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Mitaka, Tokyo, Japan, 181-8611
- Kyorin University Hospital
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Tottori
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Yonago, Tottori, Japan, 683-0853
- Tottori University Hospital
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Yamaguchi
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Ube, Yamaguchi, Japan, 755-0241
- National Hospital Organization Yamaguchi-Ube Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Data on current practice patterns for diagnosis of IIPs
Time Frame: 3-4 years
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Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.
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3-4 years
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Prevalence of each categorized IIPs
Time Frame: 3-4 years
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Investigate the prevalence of each categorized IIPs by using a recent guideline
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3-4 years
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Natural history of each categorized IIPs
Time Frame: 3-4 years
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Describe the natural history of each categorized IIPs, focusing on CT findings, FVC changes, medications, and causes of death.
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3-4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival by category of IIPs
Time Frame: 3-6 years
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3-6 years
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Hospital admission for acute exacerbations of IIPs
Time Frame: 3-6 years
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To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs
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3-6 years
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Mean change of patient-reported outcome (Saint George Respiratory Questionnaire, COPD assessment test, and Dyspnoea-12) every12 months from baseline
Time Frame: 3-4 years
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3-4 years
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Quantitative evaluation of CT findings
Time Frame: 3-6 years
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3-6 years
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Validation of second multidisciplinary discussion
Time Frame: 3-4 years
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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.
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3-4 years
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Validation of new guideline
Time Frame: 3-6 years
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If there are changes in IIPs diagnostic guidelines or severity classification during this study, these changes will be verified.
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3-6 years
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Diagnosis of IIPs in patients with IIPs at registration
Time Frame: At registration and 1 year after registration
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Describe the frequency of IIPs diagnosis using data at the time of registration.
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At registration and 1 year after registration
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Takashi Ogura, MD, Kanagawa Cardiovascular and Respiratory Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEJ030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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