UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005909 |
|---|---|
| Receipt number | R000006988 |
| Scientific Title | The Japanese randomized trial for evaluating the Efficacy of low-dose thoracic CT Screening for lung cancer |
| Date of disclosure of the study information | 2011/07/10 |
| Last modified on | 2025/07/12 10:11:12 |
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Basic information
Public title
The Japanese randomized trial for evaluating the Efficacy of low-dose thoracic CT Screening for lung cancer
Acronym
The Japanese randomized trial for evaluating the Efficacy of low-dose thoracic CT Screening for lung cancer
Scientific Title
The Japanese randomized trial for evaluating the Efficacy of low-dose thoracic CT Screening for lung cancer
Scientific Title:Acronym
The Japanese randomized trial for evaluating the Efficacy of low-dose thoracic CT Screening for lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether or not lung cancer screening using thoracic CT can decrease lung cancer mortality among the people (50-70 years old, under 30 pack-years) compared to that using conventional chest x-ray examination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
lung cancer mortality
Key secondary outcomes
sensitivity, specificity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Lung cancer screening with 2 low-dose thoracic CT and 8 chest x-ray examinnations in 10 years is provided
Interventions/Control_2
Lung cancer screening with 10 chest x-ray examinnations in 10 years is provided
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
non-smoker or smoker under 30 pack-years
written informed consent
Key exclusion criteria
prior lung cancer
multiple cancer within 5 years
lung cancer screening using CT within 10 years
severe organ failure
Target sample size
27000
Research contact person
Name of lead principal investigator
| 1st name | Motoyasu |
| Middle name | |
| Last name | Sagawa |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Division of Chest Surgery, Faculty of Medicine
Zip code
9838536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai 983-8536, Japan
TEL
022-290-8850
sagawam@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Motoyasu |
| Middle name | |
| Last name | Sagawa |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Division of Chest Surgery, Faculty of Medicine
Zip code
9838536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai 983-8536, Japan
TEL
022-290-8850
Homepage URL
http://jecs-study.jp/index.html
sagawam@tohoku-mpu.ac.jp
Sponsor or person
Institute
The JECS Study Group
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Tohoku Medical and Pharmaceutical University
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai 983-8536, Japan
Tel
022-259-1221
tikenn@hosp.tohoku-mpu.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
| 2011 | Year | 07 | Month | 10 | 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
27000
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
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2034 | 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
| 2011 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006988
