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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040724
Receipt No. 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 2020/07/30

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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
Email 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
Email karayama@hama-med.ac.jp

Sponsor
Institute Department of Internal Medicine, Second Division, Hamamatsu University School of Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046488

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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