Japanese Idiopathic Interstitial Pneumonias Registry

Active, not recruiting

• Conditions: Idiopathic Interstitial Pneumonia

• Registration Number: NCT03041623
• Lead Sponsor: North East Japan Study Group

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-18
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-03
• Primary Completion: 2021-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 867

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data on current practice patterns for diagnosis of IIPs	3-4 years	Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.
Prevalence of each categorized IIPs	3-4 years	Investigate the prevalence of each categorized IIPs by using a recent guideline
Natural history of each categorized IIPs	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

Name	Time	Method
Hospital admission for acute exacerbations of IIPs	3-6 years	To evaluate incidences, therapy and prognosis of acute respiratory deterioration in patients with IIPs
Quantitative evaluation of CT findings	3-6 years
Validation of second multidisciplinary discussion	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.
Progression-free survival by category of IIPs	3-6 years
Mean change of patient-reported outcome (Saint George Respiratory Questionnaire, COPD assessment test, and Dyspnoea-12) every12 months from baseline	3-4 years
Validation of new guideline	3-6 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	At registration and 1 year after registration	Describe the frequency of IIPs diagnosis using data at the time of registration.

Trial Locations

Locations (86)

Haruhi Respiratory Medical Hospital; 🇯🇵 Kiyosu, Aichi, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Nagoya City University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Tosei General Hospital; 🇯🇵 Seto, Aichi, Japan

Fujita Health University Hospital; 🇯🇵 Toyoake, Aichi, Japan

Hirosaki University Hospital; 🇯🇵 Hirosaki, Aomori, Japan

Kameda Medical Center; 🇯🇵 Kamogawa, Chiba, Japan

Ehime Prefectural Central Hospital; 🇯🇵 Matsuyama, Ehime, Japan

University of Fukui Hospital; 🇯🇵 Yoshida, Fukui, Japan

Fukuoka University Chikushi Hospital; 🇯🇵 Chikushino, Fukuoka, Japan

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