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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007448
Receipt No. R000005682
Scientific Title The Appropriate Interval for Endoscopic Rescreening after Screening Colonoscopy -Multicenter Trial-
Date of disclosure of the study information 2012/03/05
Last modified on 2016/01/03

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Basic information
Public title The Appropriate Interval for Endoscopic Rescreening after Screening Colonoscopy -Multicenter Trial-
Acronym The Appropriate Interval for Endoscopic Rescreening after Screening Colonoscopy -Multicenter Trial-
Scientific Title The Appropriate Interval for Endoscopic Rescreening after Screening Colonoscopy -Multicenter Trial-
Scientific Title:Acronym The Appropriate Interval for Endoscopic Rescreening after Screening Colonoscopy -Multicenter Trial-
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the appropriate interval of colonoscopy to prevent colorectal cancer
Basic objectives2 Others
Basic objectives -Others comparison among each group
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of advanced neoplasia in each group
Key secondary outcomes A characteristic of discovered advanced neoplasia

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pathient whose informed concent was obtained
Key exclusion criteria Patient whose infromed concent was not obtained
Target sample size 24000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawamura Takuji
Organization Kyoto Second Red Cross Hospital
Division name Department of Gastroenterology
Zip code
Address 355-5, Haruobi-cho, Kamigyo-ku,Kyoto, Japan
TEL 075-231-5171
Email kawamurat@kyoto2.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kawamura Takuji
Organization Kyoto Second Red Cross Hospital
Division name Department of Gastroenterology
Zip code
Address 355-5, Haruobi-cho, Kamigyo-ku,Kyoto, Japan
TEL 075-231-5171
Homepage URL
Email kawamurat@kyoto2.jrc.or.jp

Sponsor
Institute Kyoto Second Red Cross Hospital
Institute
Department

Funding Source
Organization Kyoto Preventive Medical Center
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Oda GI clinic, Kitasato University Hosptial East, The Jikei University Aoto Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 尾田胃腸内科・内科(熊本県)、北里大学東病院(神奈川県)、東京慈恵会医科大学青戸病院(東京都)、京都第二赤十字病院(京都府)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/den.12185/full
Number of participants that the trial has enrolled
Results
In the low-risk group, the odds ratios for advanced adenoma in patients undergoing moderately frequent colonoscopy (2-3 times within the previous 5 years), and frequent colonoscopy (>4 times within 5 years) were 0.33 (95% CI, 0.14-0.81) and 0.21 (95% CI, 0.02-1.60), respectively, compared with infrequent colonoscopy (once or not at all within 5 years). In the increased-risk group, the respective odds ratios were 0.48 (95% CI, 0.28-0.83) and 0.28 (95% CI, 0.12-0.64).
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 Main results already published
Date of protocol fixation
2010 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A sub-analysis about relationship between colonoscopy withdrawal time and adenoma detection rate using the original data of this study is ongoing.

Management information
Registered date
2012 Year 03 Month 05 Day
Last modified on
2016 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005682

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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