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
|Condition or disease|
|Idiopathic Interstitial Pneumonia|
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]|
|Actual Enrollment :||867 participants|
|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|
- 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.
- 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.
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
|Principal Investigator:||Takashi Ogura, MD||Kanagawa Cardiovascular and Respiratory Center|