UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041163 |
|---|---|
| Receipt number | R000047006 |
| Scientific Title | Construction of prospective registry for idiopathic interstitial pneumonias and building of their epidemiological data based on Web-based interactive multidisciplinary discussion - development of diagnostic artificial intelligence and novel biomarkers - |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2023/01/21 15:44:04 |
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Basic information
Public title
Construction of prospective registry for idiopathic interstitial pneumonias and building of their epidemiological data based on Web-based interactive multidisciplinary discussion - development of diagnostic artificial intelligence and novel biomarkers -
Acronym
IBiS study
Scientific Title
Construction of prospective registry for idiopathic interstitial pneumonias and building of their epidemiological data based on Web-based interactive multidisciplinary discussion - development of diagnostic artificial intelligence and novel biomarkers -
Scientific Title:Acronym
IBiS study
Region
| Japan |
Condition
Condition
Idiopathic interstitial pneumonias
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to establish a prospective registry of idiopathic interstitial pneumonias (IIPs) and to reveal the epidemiology of IIPs based on multidisciplinary discussion (MDD) diagnosis.
Basic objectives2
Others
Basic objectives -Others
To develop biomarkers useful for diagnosing and classifying IIPs and for predicting disease progression and prognosis of patients with IIPs, and to develop an artificial intelligence (AI)-based diagnostic system for IIPs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relative prevalence of IIPs based on MDD diagnosis
Key secondary outcomes
- Disease progression rate by IIPs classification
- Cumulative survival rate by IIPs classification
- Diagnostic accuracy and prognostic stratification of AI diagnostic system
- Diagnostic accuracy and prognostic stratification of novel biomarkers
- Cumulative incidence of acute exacerbation by IIPs classification
- Cumulative incidence of connective tissue disease/vasculitis by IIPs classification
- Cumulative incidence of lung cancer by IIPs classification
- Changes in respiratory function by IIPs classification
- Proposal-based exploratory research using this cohort data
- Search for new biomarkers using stocked serum samples
- Survey of end-of-life care/palliative care
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 newly diagnosed with IIPs at each hospital in Japan
Key exclusion criteria
Cases that meet any of the following criteria are excluded from this study.
- Patients who have difficulty cooperating with various tests required in this study, such as respiratory function tests
- Patients who have undergone lobectomy or more extensive pneumonectomy by the time of registration
- Patients who have not been interviewed or tested enough to diagnose IIPs by the time the central MDD diagnosis team makes a diagnosis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL
+81-53-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hironao |
| Middle name | |
| Last name | Hozumi |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL
+81-53-435-2263
Homepage URL
https://portal.mdd.systems/
hozumi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
Tel
+81-53-435-2680
rinri@hama-med.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 | 20 | Day |
Related information
URL releasing protocol
https://portal.mdd.systems/
Publication of results
Unpublished
Result
URL related to results and publications
https://portal.mdd.systems/
Number of participants that the trial has enrolled
1160
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 | 18 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Prospective collection of clinical findings (patient background/characteristics, blood tests, physiological tests, autoantibodies, connective tissue disease/vasculitis-related symptoms and physical findings), chest HRCT images, and lung pathological specimens
- MDD diagnosis by pulmonologist, thoracic radiologist, and lung pathologist at enrollment and at end of follow-up
- Clinical outcomes (survival/death, cause of death, acute exacerbation, change of diagnosis, lung cancer, connective tissue disease/vasculitis)
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
