Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03041623

Japanese Idiopathic Interstitial Pneumonias Registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Idiopathic Interstitial Pneumonia Idiopathic Interstitial Pneumonias Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

20 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haruhi Respiratory Medical Hospital, Kiyosu, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 20 and 84 years
  • Patients with idiopathic pulmonary fibrosis (IPF) and other IIPs diagnosis within 6 months before registration at each facility
  • Patients from whom written informed consent has been obtained regarding participation in this study and follow-up observation

Exclusion criteria

  • Patients for whom the tests (such as the lung function test) conducted in this study could not be performed
  • Patients who underwent pulmonary resection
  • Patients undergoing dialysis
  • Patients with cancer treated at the time of registration or those planning to receive treatment in the future

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Progression-free survival by category of IIPs

    Time frame: 3-6 years

  2. Hospital admission for acute exacerbations of IIPs

    Time frame: 3-6 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: 3-6 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: 3-6 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.

Sponsors and collaborators

Lead sponsor

North East Japan Study Group

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Acronym: JIPS

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Feb 3, 2017
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.