UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005988 |
|---|---|
| Receipt number | R000006955 |
| Scientific Title | Basic Research for Population-Based Colorectal Cancer Screening Targeted an Isolated Island: Niijima Study |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2016/06/21 21:22:06 |
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Basic information
Public title
Basic Research for Population-Based Colorectal Cancer Screening Targeted an Isolated Island: Niijima Study
Acronym
NIIJIMA STUDY
Scientific Title
Basic Research for Population-Based Colorectal Cancer Screening Targeted an Isolated Island: Niijima Study
Scientific Title:Acronym
NIIJIMA STUDY
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establishment for the ideal model of colorectal cancer screening in the isolated island
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of colorectal cancer screening
Key secondary outcomes
Improve effectiveness for prevalence of colorectal cancer screening by call-recall method
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
FOBT/Total Colonoscopy
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All people between 40 and 79 years who lives in Niijima island.
Key exclusion criteria
Over 80 years
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Matsuda |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
tamatsud@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Matsuda |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
tamatsud@ncc.go.jp
Sponsor or person
Institute
Niijima Study Working Group
Institute
Department
Personal name
Funding Source
Organization
Grants-in Aid for Clinical Cancer Research from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
国立がん研究センター中央病院（National Cancer Center Hospital）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | 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 | 17 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006955
