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Japanese Idiopathic Interstitial Pneumonias Registry (JIPS)

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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

Study Description
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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.

Condition or disease
Idiopathic Interstitial Pneumonia

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 867 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Japanese Idiopathic Interstitial Pneumonias Registry
Actual Study Start Date : December 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Data on current practice patterns for diagnosis of IIPs [ Time Frame: 3-4 years ]
    Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.

  2. Prevalence of each categorized IIPs [ Time Frame: 3-4 years ]
    Investigate the prevalence of each categorized IIPs by using a recent guideline

  3. 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.


Secondary Outcome Measures :
  1. Progression-free survival by category of IIPs [ Time Frame: 3-4 years ]
  2. 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

  3. 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 ]
  4. Quantitative evaluation of CT findings [ Time Frame: 3-4 years ]
  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed IIPs within 6 months before registration
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041623


Locations
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Sponsors and Collaborators
North East Japan Study Group
Boehringer Ingelheim
Investigators
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Principal Investigator: Takashi Ogura, MD Kanagawa Cardiovascular and Respiratory Center
More Information
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Additional Information:

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Responsible Party: North East Japan Study Group
ClinicalTrials.gov Identifier: NCT03041623    
Other Study ID Numbers: NEJ030
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Keywords provided by North East Japan Study Group:
IIPs
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases, Interstitial
Idiopathic Interstitial Pneumonias
Pulmonary Fibrosis
 Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections