Providing Multidisciplinary ILD diagnoses (PROMISE) study

Providing Multidisciplinary ILD diagnoses (PROMISE) study - Providing Multidisciplinary ILD diagnoses (PROMISE) study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040678

Enrollment

2700

Registered

2020-07-01

Start date

2020-09-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial lung disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who were pointed out having interstital lung disease within 24 months before at each hospital in Japan.

Exclusion criteria

Exclusion criteria: Cases that meet any of the following criteria are excluded from this study. (1) Cases where it is not possible to cooperate with various tests conducted in this study, such as respiratory function tests. (2) Patients who have undergone more than lobectomy by the time of registration. (3) Patients who have not been sufficiently interviewed and tested to diagnose interstitial pneumonia by the time the central diagnosis team makes a diagnosis.

Design outcomes

Primary

Measure	Time frame
To investigate the relative prevalence of each categorized ILD including Idiopathic interstitial pneumonias including IPF, connective tissue disease associated ILD, chronic hypersensitivity pneumonitis, etc. in real world.	—

Secondary

Measure	Time frame
Key Secondary Endpoint; To reveal the relationship between disease progression and baseline parameters, HRCT images and pattern, and pathological pattern. Moreover, to create a clinical prediction model. Secondary Endpoints; To investigate progressive phenotype as defined by fulfilling at least one of the criteria below of fibrotic changes (progression set point) within the last 24 months regardless of treatment considered appropriate in individual ILDs: 1. decline in FVC % predicted (% pred) based on >=10% relative decline 2. decline in FVC % pred based on >=5 to <10% relative decline in FVC combined with worsening of respiratory symptoms as assessed by the site investigator 3. decline in FVC % pred based on >=5 to <10% relative decline in FVC combined with increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator 4. worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator independent of FVC change.	—

Measure

Time frame

Key Secondary Endpoint; To reveal the relationship between disease progression and baseline parameters, HRCT images and pattern, and pathological pattern. Moreover, to create a clinical prediction model. Secondary Endpoints; To investigate progressive phenotype as defined by fulfilling at least one of the criteria below of fibrotic changes (progression set point) within the last 24 months regardless of treatment considered appropriate in individual ILDs: 1. decline in FVC % predicted (% pred) based on >=10% relative decline 2. decline in FVC % pred based on >=5 to <10% relative decline in FVC combined with worsening of respiratory symptoms as assessed by the site investigator 3. decline in FVC % pred based on >=5 to <10% relative decline in FVC combined with increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator 4. worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator independent of FVC change.

—

Countries

Japan

Contacts

Public ContactTaiki Furukawa

Nagoya University Hospital Medical IT Center

promise@med.nagoya-u.ac.jp+81-52-744-2077

Outcome results