UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040724 |
|---|---|
| Receipt number | R000046488 |
| Scientific Title | Screening of interstitial pneumonias by quantification of chest X-ray |
| Date of disclosure of the study information | 2020/06/11 |
| Last modified on | 2022/07/20 11:58:32 |
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Basic information
Public title
Screening of interstitial pneumonias by quantification of chest X-ray
Acronym
IP screening by chest X-ray
Scientific Title
Screening of interstitial pneumonias by quantification of chest X-ray
Scientific Title:Acronym
IP screening by chest X-ray
Region
| Japan |
Condition
Condition
Interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the findings of chest X-ray for the screening of interstitial pneumonias.
Basic objectives2
Others
Basic objectives -Others
Development of measurements
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Structural changes in chest X-ray that can evaluate the volume loss of the lungs
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with interstitial pneumonias who underwent chest X-ray, chest CT and spirometry within 4 weeks
2) Control patients who do not have interstitial pneumonias or any pulmonary diseases and underwent chest X-ray, chest CT and spirometry within 4 weeks
3) Clinically stable patients who do not have a worsening of diseases.
Key exclusion criteria
1) Patients who lacks any of chest X-ray, chest CT and spirometry
2) chest X-ray, chest CT and spirometry were underwent over 4 weeks.
3) Clinically unstable patients who have worsening of diseases within 4 weeks.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Department of Internal Medicine, Second Division
Zip code
4313192
Address
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
TEL
0534352263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Karayama |
Organization
Hamamatsu University School of Medicine
Division name
Department of Chemotherapy
Zip code
4313192
Address
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
TEL
0534352419
Homepage URL
karayama@hama-med.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Second Division, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Second Division, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Clinical Trial
Address
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
Tel
0534352680
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 | 06 | Month | 11 | 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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2020 | Year | 06 | Month | 11 | Day |
Last modified on
| 2022 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046488
