<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041623</url>
  </required_header>
  <id_info>
    <org_study_id>NEJ030</org_study_id>
    <nct_id>NCT03041623</nct_id>
  </id_info>
  <brief_title>Japanese Idiopathic Interstitial Pneumonias Registry</brief_title>
  <acronym>JIPS</acronym>
  <official_title>Japanese Idiopathic Interstitial Pneumonias Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North East Japan Study Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>North East Japan Study Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An objective of JIPS Registry is to examine disease behavior of idiopathic interstitial&#xD;
      pneumonias (IIPs), considering classification, background, and diagnostic methods based on&#xD;
      American Thoracic Society (ATS)/ European Respiratory Society(ERS) /Japanese Respiratory&#xD;
      Society (JRS)/ Latin American Thoracic Association (ALAT) guidelines for diagnosis and the&#xD;
      ATS/ERS classification of 2002 and 2013.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      JIPS Registry is a multi-site, non-interventional, prospective observation study of patients&#xD;
      with newly diagnosed IIPs in Japan. At least 600 patients will be registered for 16 months at&#xD;
      approximately 80 sites in Japan.&#xD;
&#xD;
      Primary research question is to determine the natural history of each category of IIPs at&#xD;
      registration, patient background and diagnosis methods will be considered. Furthermore, the&#xD;
      present treatment patterns and disease behavior (CT and forced vital capacity (FVC) changes,&#xD;
      as well as changes in interstitial pneumonia markers, etc.) will also be investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Actual">March 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Data on current practice patterns for diagnosis of IIPs</measure>
    <time_frame>3-4 years</time_frame>
    <description>Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of each categorized IIPs</measure>
    <time_frame>3-4 years</time_frame>
    <description>Investigate the prevalence of each categorized IIPs by using a recent guideline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural history of each categorized IIPs</measure>
    <time_frame>3-4 years</time_frame>
    <description>Describe the natural history of each categorized IIPs, focusing on CT findings, FVC changes, medications, and causes of death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival by category of IIPs</measure>
    <time_frame>3-6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admission for acute exacerbations of IIPs</measure>
    <time_frame>3-6 years</time_frame>
    <description>To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change of patient-reported outcome (Saint George Respiratory Questionnaire, COPD assessment test, and Dyspnoea-12) every12 months from baseline</measure>
    <time_frame>3-4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative evaluation of CT findings</measure>
    <time_frame>3-6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validation of second multidisciplinary discussion</measure>
    <time_frame>3-4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validation of new guideline</measure>
    <time_frame>3-6 years</time_frame>
    <description>If there are changes in IIPs diagnostic guidelines or severity classification during this study, these changes will be verified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of IIPs in patients with IIPs at registration</measure>
    <time_frame>At registration and 1 year after registration</time_frame>
    <description>Describe the frequency of IIPs diagnosis using data at the time of registration.</description>
  </secondary_outcome>
  <enrollment type="Actual">867</enrollment>
  <condition>Idiopathic Interstitial Pneumonia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed IIPs within 6 months before registration&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged between 20 and 84 years&#xD;
&#xD;
          2. Patients with idiopathic pulmonary fibrosis (IPF) and other IIPs diagnosis within 6&#xD;
             months before registration at each facility&#xD;
&#xD;
          3. Patients from whom written informed consent has been obtained regarding participation&#xD;
             in this study and follow-up observation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients for whom the tests (such as the lung function test) conducted in this study&#xD;
             could not be performed&#xD;
&#xD;
          2. Patients who underwent pulmonary resection&#xD;
&#xD;
          3. Patients undergoing dialysis&#xD;
&#xD;
          4. Patients with cancer treated at the time of registration or those planning to receive&#xD;
             treatment in the future&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Takashi Ogura, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kanagawa Cardiovascular and Respiratory Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haruhi Respiratory Medical Hospital</name>
      <address>
        <city>Kiyosu</city>
        <state>Aichi</state>
        <zip>452-0962</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>466-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>467-8601</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tosei General Hospital</name>
      <address>
        <city>Seto</city>
        <state>Aichi</state>
        <zip>489-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital</name>
      <address>
        <city>Toyoake</city>
        <state>Aichi</state>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirosaki University Hospital</name>
      <address>
        <city>Hirosaki</city>
        <state>Aomori</state>
        <zip>036-8562</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kameda Medical Center</name>
      <address>
        <city>Kamogawa</city>
        <state>Chiba</state>
        <zip>296-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime Prefectural Central Hospital</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <zip>790-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Fukui Hospital</name>
      <address>
        <city>Yoshida</city>
        <state>Fukui</state>
        <zip>910-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Chikushi Hospital</name>
      <address>
        <city>Chikushino</city>
        <state>Fukuoka</state>
        <zip>818-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aso Iizuka Hospital</name>
      <address>
        <city>Iizuka</city>
        <state>Fukuoka</state>
        <zip>820-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogaki Municipal Hospital</name>
      <address>
        <city>Ogaki</city>
        <state>Gifu</state>
        <zip>503-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma University Hospital</name>
      <address>
        <city>Maebashi</city>
        <state>Gunma</state>
        <zip>371-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asahikawa Medical University Hospital</name>
      <address>
        <city>Asahikawa</city>
        <state>Hokkaido</state>
        <zip>078-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Occupational and Environmental Health Japan</name>
      <address>
        <city>Kitakyushu</city>
        <state>Hukuoka</state>
        <zip>807-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Himeji Medical Center</name>
      <address>
        <city>Himeji</city>
        <state>Hyogo</state>
        <zip>670-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center West Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>653-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ibarakihigashi National Hospital</name>
      <address>
        <city>Naka</city>
        <state>Ibaraki</state>
        <zip>319-1113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Prefectural Central Hospital</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <zip>020-0066</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Isehara</city>
        <state>Kanagawa</state>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Marianna University School of Medicine Hospital</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>216-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Fujigaoka Hospital</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>227-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cardiovascular and Respiratory Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>236-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kochi medical School Hospital</name>
      <address>
        <city>Nankoku</city>
        <state>Kochi</state>
        <zip>783-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Ise Hospital</name>
      <address>
        <city>Ise</city>
        <state>Mie</state>
        <zip>516-8512</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsuzaka City Hospital</name>
      <address>
        <city>Matsuzaka</city>
        <state>Mie</state>
        <zip>515-8544</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Kousei Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>980-0873</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku Medical and Pharmaceutical University Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>983-8512</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suwa Central Hospital</name>
      <address>
        <city>Chino</city>
        <state>Nagano</state>
        <zip>391-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinshu University Hospital</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saku Central Hospital Advanced Care Center</name>
      <address>
        <city>Saku</city>
        <state>Nagano</state>
        <zip>385-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tenri Hospital</name>
      <address>
        <city>Tenri</city>
        <state>Nara</state>
        <zip>632-8552</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital</name>
      <address>
        <city>Kurashiki</city>
        <state>Okayama</state>
        <zip>710-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okinawa Chubu Hospital</name>
      <address>
        <city>Uruma</city>
        <state>Okinawa</state>
        <zip>904-2293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinki University Hospital</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kinki-chuo Chest Medical Center</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <zip>591-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Koshigaya Hospital</name>
      <address>
        <city>Koshigaya</city>
        <state>Saitama</state>
        <zip>343-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiga University of Medical Science Hospital</name>
      <address>
        <city>Otsu</city>
        <state>Shiga</state>
        <zip>520-2192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shimane University Hospital</name>
      <address>
        <city>Izumo</city>
        <state>Shimane</state>
        <zip>693-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Matsue Medical Center</name>
      <address>
        <city>Matsue</city>
        <state>Shimane</state>
        <zip>690-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamamatsu Rosai Hospital</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <zip>430-8525</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seirei Hamamatsu General Hospital</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <zip>430-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamamatsu University Hospital</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <zip>431-3126</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seirei Mikatahara General Hospital</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <zip>433-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jichi Medical University</name>
      <address>
        <city>Shimotsuke</city>
        <state>Tochigi</state>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Tokyo National Hospital</name>
      <address>
        <city>Kiyose</city>
        <state>Tokyo</state>
        <zip>204-8585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hospital</name>
      <address>
        <city>Mitaka</city>
        <state>Tokyo</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tottori University Hospital</name>
      <address>
        <city>Yonago</city>
        <state>Tottori</state>
        <zip>683-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Yamaguchi-Ube Medical Center</name>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <zip>755-0241</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba University Hospital</name>
      <address>
        <city>Chiba</city>
        <zip>260-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Chiba-East-Hospital</name>
      <address>
        <city>Chiba</city>
        <zip>260-8712</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital.</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital</name>
      <address>
        <city>Fukushima</city>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Prefectural Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima University Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saiseikai Kumamoto Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>861-4193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki</city>
        <zip>852-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical and Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Minami-Okayama Medical Center</name>
      <address>
        <city>Okayama</city>
        <zip>701-0304</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Saitama Hospital</name>
      <address>
        <city>Saitama</city>
        <zip>330-8553</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Hospital</name>
      <address>
        <city>Tochigi</city>
        <zip>321-0293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima</city>
        <zip>770-8053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8470</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jikei University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical and Dental University</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NTT Medical Center Tokyo</name>
      <address>
        <city>Tokyo</city>
        <zip>141-8625</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Omori Medical Center</name>
      <address>
        <city>Tokyo</city>
        <zip>143-8541</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Medical Center</name>
      <address>
        <city>Tokyo</city>
        <zip>150-8935</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JR Tokyo General Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>151-8528</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Tokyo Medical Center</name>
      <address>
        <city>Tokyo</city>
        <zip>152-8902</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center for Global Health and Medicine</name>
      <address>
        <city>Tokyo</city>
        <zip>162-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teikyo University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>173-8605</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihon University Itabashi Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>173-8610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toyama University Hospital</name>
      <address>
        <city>Toyama</city>
        <zip>930-0194</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamagata City Hospital Saiseikan</name>
      <address>
        <city>Yamagata</city>
        <zip>990-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IIPs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
    <mesh_term>Idiopathic Interstitial Pneumonias</mesh_term>
    <mesh_term>Hamman-Rich Syndrome</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041623
org study id: NEJ030
nct id: NCT03041623
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Data on current practice patterns for diagnosis of IIPs
time frame: 3-4 years
description: Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.
measure: Prevalence of each categorized IIPs
time frame: 3-4 years
description: Investigate the prevalence of each categorized IIPs by using a recent guideline
measure: Natural history of each categorized IIPs
time frame: 3-4 years
description: Describe the natural history of each categorized IIPs, focusing on CT findings, FVC changes, medications, and causes of death.
measure: Progression-free survival by category of IIPs
time frame: 3-6 years
measure: Hospital admission for acute exacerbations of IIPs
time frame: 3-6 years
description: To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs
measure: 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
measure: Quantitative evaluation of CT findings
time frame: 3-6 years
measure: Validation of second multidisciplinary discussion
time frame: 3-4 years
description: 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.
measure: Validation of new guideline
time frame: 3-6 years
description: If there are changes in IIPs diagnostic guidelines or severity classification during this study, these changes will be verified.
measure: Diagnosis of IIPs in patients with IIPs at registration
time frame: At registration and 1 year after registration
description: Describe the frequency of IIPs diagnosis using data at the time of registration.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 84 Years
healthy volunteers: No
last name: Takashi Ogura, MD
role: Principal Investigator
affiliation: Kanagawa Cardiovascular and Respiratory Center
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country: Japan
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Lung Diseases, Interstitial
mesh term: Idiopathic Interstitial Pneumonias
mesh term: Hamman-Rich Syndrome
mesh term: Pulmonary Fibrosis