UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007448 |
|---|---|
| Receipt number | 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 18:36:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kawamurat@kyoto2.jrc.or.jp
Sponsor or person
Institute
Kyoto Second Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
