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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040678
Receipt No. R000046337
Scientific Title Providing Multidisciplinary ILD diagnoses (PROMISE) study
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/06

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Basic information
Public title Providing Multidisciplinary ILD diagnoses (PROMISE) study
Acronym Providing Multidisciplinary ILD diagnoses (PROMISE) study
Scientific Title Providing Multidisciplinary ILD diagnoses (PROMISE) study
Scientific Title:Acronym Providing Multidisciplinary ILD diagnoses (PROMISE) study
Region
Japan

Condition
Condition Interstitial lung disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this prospective cohort study of all Interstitial lung disease (ILD) in ILD referral and non-referral centers in Japan, is to investigate the relative prevalence of each categorized ILD, such as IPF, connective tissue disease associated ILD, and/or chronic hypersensitivity pneumonitis in real world, using web based central MDD with diagnostic ontology. This web based MDD system can provide ILD expert diagnosis to non-expert hospitals and it may change clinician's behavior for ILD patients in Japan.
Basic objectives2 Others
Basic objectives -Others To reveal the relationship between disease progression and baseline parameters, HRCT images and pattern, and pathological pattern. Moreover, to create a clinical prediction model. Furthermore, to investigate progressive phenotype.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 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.
Key secondary outcomes 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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were pointed out having interstital lung disease within 24 months before at each hospital in Japan.
Key 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.
Target sample size 2700

Research contact person
Name of lead principal investigator
1st name Naozumi
Middle name
Last name Hashimoto
Organization Nagoya University Graduate School of Medicine
Division name Respiratory Medicine
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL +81-52-744-2167
Email hashinao@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Taiki
Middle name
Last name Furukawa
Organization Nagoya University Hospital
Division name Medical IT Center
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL +81-52-744-2077
Homepage URL
Email promise@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University Graduate School of Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel 052-741-2111
Email ethics@med.nagoya-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 30 Day
Last follow-up date
2025 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective collection of clinical findings (blood tests, physiological tests), chest CT images, and lung pathological specimens regarding patients as having interstitial lung disease, and an integrated clinical, image, and pathological database was constructed via the Web.
At the time of enrollment and at the end of follow-up, a diagnosis will be made based on multidisciplinary discussion (MDD) via the Web by a pulmonologist, thoracic radiologist, and lung pathologist.
Clinical manifestation was analyzed in each disease based on MDD diagnosis.
In addition, we will compare the existing diagnostic artificial intelligence system and prognosis prediction system with MDD diagnosis and actual prognosis.

Management information
Registered date
2020 Year 06 Month 06 Day
Last modified on
2020 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046337

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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