UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030415 |
|---|---|
| Receipt number | R000034727 |
| Scientific Title | Japanese Multi-Center Study for Utility of 3D Computer-Aided Detection System at Lung Cancer Screening with Low-dose CT Protocol |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/05/09 21:52:48 |
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Basic information
Public title
Japanese Multi-Center Study for Utility of 3D Computer-Aided Detection System at Lung Cancer Screening with Low-dose CT Protocol
Acronym
Japanese Multi-Center Trial of 3D CAD System and Low-Dose CT Protocol for Lung cancer Screening
Scientific Title
Japanese Multi-Center Study for Utility of 3D Computer-Aided Detection System at Lung Cancer Screening with Low-dose CT Protocol
Scientific Title:Acronym
Japanese Multi-Center Trial of 3D CAD System and Low-Dose CT Protocol for Lung cancer Screening
Region
| Japan |
Condition
Condition
Pulmonary nodule
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of nodule detection capability among CAD system alone and CAD system with concurrent and second reading method by physicians.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Results of compared nodule detection capability among CAD system alone and CAD system with concurrent and second reading method by physicians.
Key secondary outcomes
1. Comparison of quantitative image quality at various dose CTs among FBP, AIDR 3D and FIRST
2. Comparison of qualitative image quality at various dose CTs among FBP, AIDR 3D and FIRST
3. Comparison for nodule detection capability of CAD system among standard-, reduced- and ultra-low-dose CTs
4. Comparison for nodule detection capability at standard-, reduced- and ultra-low-dose CTs among CAD system alone and CAD system with concurrent and second reading methods by physicians
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Comparison of nodule detection capability among CAD alone and CAD with concurrent and second reading methods with physicians
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Equal to or more than 40-years old
2. Written informed consent is obtained.
3. Patients with radiological, microbacterial, histological and laboratorial as well as more than two-years follow-up CT examinations are performed.
Key exclusion criteria
1. Already included subject
2. Pregnant woman or female with possibility for pregnancy
3. Patients who undergo standard-dose CT examination and don't allow any further radiation exposure.
4. Patient who is considered as non inclusive by researchers
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Ohno |
Organization
Kobe University Hospital
Division name
Department of Radiology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan
TEL
078-382-6104
yosirad@kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Seki |
Organization
Kobe University Hospital
Division name
Department of Radiology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan
TEL
+81-78-382-6104
Homepage URL
klfsiena@yahoo.co.jp
Sponsor or person
Institute
Department of Radiology, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大原綜合病院（福島県），神奈川県立循環器呼吸器病センター（神奈川県），産業医科大学病院（福岡），静岡県立がんセンター（静岡）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to the principle investigators' moving out from Kobe University, this research project was terminated on February 25, 2019.
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034727
