Japanese Idiopathic Interstitial Pneumonias Registry (JIPS)

• ClinicalTrials.gov Identifier: NCT03041623
• Recruitment Status: Active, not recruiting
• First Posted: February 3, 2017
• Last Update Posted: October 1, 2019
• Sponsor: North East Japan Study Group
• 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

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

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

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