UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042819 |
|---|---|
| Receipt number | R000048877 |
| Scientific Title | Observational study to grasp the current status of colonoscopy by Practical doctor |
| Date of disclosure of the study information | 2020/12/22 |
| Last modified on | 2021/10/29 16:04:21 |
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Basic information
Public title
Observational study to grasp the current status of colonoscopy by Practical doctor
Acronym
Observational study to grasp the current status of colonoscopy by Practical doctor
Scientific Title
Observational study to grasp the current status of colonoscopy by Practical doctor
Scientific Title:Acronym
Observational study to grasp the current status of colonoscopy by Practical doctor
Region
| Japan |
Condition
Condition
Incident
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Grasping the current status and incidents of colonoscopy by Practical doctor
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Correlation between mean cecal transit time and adenoma detection rate
2)Understanding of adverse events during colonoscopy
Key secondary outcomes
1)To search and comprehensively calculate descriptive statistics of obtained data.
2)Summarize adverse events and calculate descriptive statistics.
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
All patients who underwent colonoscopy during the enrollment period at the participating institutions
Key exclusion criteria
The person who expressed a refusal after seeing the opt-out public document.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular-Targeting Prevention
Zip code
602-8566
Address
Kawaramachi-hiroko-ji, Kamigyo-ku, Kyoto 602-8566
TEL
075-251-5111
cancer@gol.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular-Targeting Prevention
Zip code
602-8566
Address
Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN
TEL
0752515111
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Molecular-Targeting Prevention
Institute
Department
Personal name
Funding Source
Organization
Practical Study Group on Colonoscopy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kawaramachi-hiroko-ji, Kamigyo-ku, Kyoto 602-8566
Tel
0752515111
rinri@koto.kpu-m.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
| 2020 | Year | 12 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation: Medical records and questionnaires to facility representatives
Management information
Registered date
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048877
