UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001980 |
|---|---|
| Receipt number | R000002416 |
| Scientific Title | Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening |
| Date of disclosure of the study information | 2009/05/18 |
| Last modified on | 2020/08/04 18:13:50 |
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Basic information
Public title
Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Acronym
Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Scientific Title
Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Scientific Title:Acronym
Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify effectiveness of total colonoscopy compared to fecal occult blood test in colorectal cancer screening
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality rate of colorectal cancer
Key secondary outcomes
Sensitivity and specificity of colorectal cancer, cumulative incidence rate of advanced colorectal cancer, and cumulative incidence rate of invasive colorectal cancer
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 not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Fecal occult blood test added to total colonoscopy
Interventions/Control_2
Fecal occult blood test
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.40 years to 74 years when registered
2.Signed the informed consent to participate in the study
Key exclusion criteria
1.History of colorectal cancer
2.Familial adenomatous polyposis, family history of hereditary non-polyposis colorectal cancer and inflammatory bowel disease (ulcerative colitis and crohn' s disease)
3.Malignant disease other colorectal cancer within 5 years
4.In severe condition, who are expected to live for 5 years
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Shin-ei |
| Middle name | |
| Last name | Kudo |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chuo Chigasaki Tsuzuki-ku Yokohama-city Kanagawa Japan
TEL
045-945-0686
kudos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahisa |
| Middle name | |
| Last name | Matsuda |
Organization
National Cancer Center Hospital
Division name
Research Center for Cancer Prevention and Screening
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo Japan
TEL
03-3542-2511
Homepage URL
tamatsud@ncc.go.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Ethics Review Committee
Address
5-1-1 Tsukiji Chuo-ku Tokyo Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
仙北市健康管理センター
大仙市健康増進センター
仙北市立角館総合病院
秋田赤十字病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002416
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
