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Japanese Idiopathic Interstitial Pneumonias Registry (JIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041623
Recruitment Status : Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
North East Japan Study Group

Tracking Information
First Submitted Date December 18, 2016
First Posted Date February 3, 2017
Last Update Posted Date October 1, 2019
Actual Study Start Date December 2016
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2017)
  • 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 Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 29, 2019)
  • 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.
  • Validation of new guideline [ Time Frame: 3-4 years ]
    If there are changes in IIPs diagnostic guidelines or severity classification during this study, these changes will be verified.
  • Diagnosis of IIPs in patients with IIPs at registration [ Time Frame: At registration and 1 year after registration ]
    Describe the frequency of IIPs diagnosis using data at the time of registration.
Original Secondary Outcome Measures
 (submitted: January 31, 2017)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Japanese Idiopathic Interstitial Pneumonias Registry
Official Title Japanese Idiopathic Interstitial Pneumonias Registry
Brief 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 (ALAT) guidelines for diagnosis and the ATS/ERS classification of 2002 and 2013.
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 Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Newly diagnosed IIPs within 6 months before registration
Condition Idiopathic Interstitial Pneumonia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 29, 2019)
867
Original Estimated Enrollment
 (submitted: January 31, 2017)
800
Estimated Study Completion Date March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03041623
Other Study ID Numbers NEJ030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party North East Japan Study Group
Study Sponsor North East Japan Study Group
Collaborators Boehringer Ingelheim
Investigators
Principal Investigator: Takashi Ogura, MD Kanagawa Cardiovascular and Respiratory Center
PRS Account North East Japan Study Group
Verification Date September 2019