UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036438 |
|---|---|
| Receipt number | R000041519 |
| Scientific Title | Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases |
| Date of disclosure of the study information | 2019/04/08 |
| Last modified on | 2022/04/10 12:52:49 |
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Basic information
Public title
Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases
Acronym
Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases
Scientific Title
Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases
Scientific Title:Acronym
Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases
Region
| Japan |
Condition
Condition
Thoracic surgical diseases
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare morphological features in patients with thoracic surgical diseases among standing and supine positions using upright and conventional CT. To explore the relationship between morphological parameters on CT images and clinical data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological parameters on CT images
Concrete primary outcomes are not determined, because this study is an exploratory study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Upright CT scan in a standing position
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
1. Subjects who are referred for CT examination for the assessment of thoracic surgical diseases
2. Age equal to or more than 20 years
3. Subjects who provide written informed consent
Key exclusion criteria
1. Known or possible pregnancy
2. Subjects who are not able to undergo CT examination in a standing position
3. Subjects who do not provide written informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Jinzaki |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo.
TEL
03-5363-3836
jinzaki@rad.keio.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Asakura |
Organization
Keio University School of Medicine
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo.
TEL
03-5363-3806
Homepage URL
asakura@z6.keio.jp
Sponsor or person
Institute
Department of Radiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Keio University School of Medicine Ethics committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo.
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2019 | Year | 04 | Month | 08 | 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
| 2019 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041519
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
