Japanese Idiopathic Interstitial Pneumonias Registry

N/AActive Not RecruitingNCT03041623

North East Japan Study Group867 enrolled

Overview

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.

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

Enrollment

867

Conditions

Idiopathic Interstitial Pneumonia

Eligibility

Sex: ALLMin age: 20 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (86)

Outcomes

Primary Outcomes

Data on current practice patterns for diagnosis of IIPs

Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.

Time frame: 3-4 years

Prevalence of each categorized IIPs

Investigate the prevalence of each categorized IIPs by using a recent guideline

Time frame: 3-4 years

Natural history of each categorized IIPs

Describe the natural history of each categorized IIPs, focusing on CT findings, FVC changes, medications, and causes of death.

Time frame: 3-4 years

Secondary Outcomes

Progression-free survival by category of IIPs

Time frame: 3-6 years

Hospital admission for acute exacerbations of IIPs

To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs

Time frame: 3-6 years

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: 3-6 years

Validation of second multidisciplinary discussion

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.

Data from ClinicalTrials.gov

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Haruhi Respiratory Medical Hospital

Kiyosu, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Tosei General Hospital

Seto, Aichi-ken, Japan

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Chiba University Hospital

Chiba, Chiba, Japan

National Hospital Organization Chiba-East-Hospital

Chiba, Chiba, Japan

Kameda Medical Center

Kamogawa, Chiba, Japan

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

...and 76 more locations