UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017776 |
|---|---|
| Receipt number | R000020591 |
| Scientific Title | Prospective study for the utility of Computed Tomography after colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2015/06/03 |
| Last modified on | 2017/12/11 13:38:40 |
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Basic information
Public title
Prospective study for the utility of Computed Tomography after colorectal endoscopic submucosal dissection
Acronym
Prospective study for the utility of Computed Tomography after colorectal endoscopic submucosal dissection
Scientific Title
Prospective study for the utility of Computed Tomography after colorectal endoscopic submucosal dissection
Scientific Title:Acronym
Prospective study for the utility of Computed Tomography after colorectal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
analysis for findings of CT after colorectal ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CT findings and clinical course after colorectal ESD
Key secondary outcomes
treatment outcome and complication rate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent colorectal ESD
Key exclusion criteria
pregnant woman
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kingo Hirasawa |
Organization
Yokohama City University medical center
Division name
division of endoscopy
Zip code
Address
4-57 Urafunecho yokohama-city Kanagawa Pref.
TEL
045-261-5656
kingo-h@uraph.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kingo Hirasawa |
Organization
Yokohama City University medical center
Division name
division of endoscopy
Zip code
Address
4-57 Urafunecho yokohama-city Kanagawa Pref.
TEL
045-261-5656
Homepage URL
kingo-h@uraph.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University medical center division of endoscopy
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
横浜市立大学附属市民総合医療センター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 03 | 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
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 08 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
clinical course after colorectal ESD
Management information
Registered date
| 2015 | Year | 06 | Month | 02 | Day |
Last modified on
| 2017 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020591
| 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 |
