Clinical Trial: Japanese Idiopathic Interstitial Pneumonias Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Japanese Idiopathic Interstitial Pneumonias Registry

Brief Summary: An objective of JIPS Registry is to examine disease prevalence 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 Summary:

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 prevalence 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.


Sponsor: North East Japan Study Group

Current Primary Outcome:

  • Data on current practice patterns for diagnosis of IIPs [ Time Frame: 3-4 years ]
    Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.
  • Prevalence of each categorized IIPs [ Time Frame: 3-4 years ]
    Investigate the prevalence of each categorized IIPs by using a recent guideline
  • Natural history of each categorized IIPs [ Time Frame: 3-4 years ]
    Describe the natural history of each categorized IIPs, focusing on CT findings, FVC changes, medications, and causes of death.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression-free survival by category of IIPs [ Time Frame: 3-4 years ]
  • Hospital admission for acute exacerbations of IIPs [ Time Frame: 3-4 years ]
    To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs
  • 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 ]
  • Quantitative evaluation of CT findings [ Time Frame: 3-4 years ]
  • Validation of second multidisciplinary discussion [ Time Frame: 3-4 years ]
    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.


Original Secondary Outcome: Same as current

Information By: North East Japan Study Group

Dates:
Date Received: December 18, 2016
Date Started: December 2016
Date Completion: March 2021
Last Updated: May 17, 2017
Last Verified: May 2017