UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040678 |
|---|---|
| Receipt number | R000046337 |
| Scientific Title | Providing Multidisciplinary ILD diagnoses (PROMISE) study |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2023/12/19 11:26:25 |
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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 | Makoto |
| Middle name | |
| Last name | Ishii |
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
mishii@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
https://portal.mdd.systems/
promise@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
https://portal.mdd.systems/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
2789
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 24 | 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
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046337
