UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026349 |
|---|---|
| Receipt number | R000030268 |
| Scientific Title | Comparison of NBI, chromoendoscopy, and endoscopic ultrasonography to predict deep submucosal invasion in scheduled ESD patients |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/03/01 11:50:01 |
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Basic information
Public title
Comparison of NBI, chromoendoscopy, and endoscopic ultrasonography
to predict deep submucosal invasion in scheduled ESD patients
Acronym
Comparison of NBI, chromoendoscopy, and endoscopic ultrasonography
to predict deep submucosal invasion in scheduled ESD patients
Scientific Title
Comparison of NBI, chromoendoscopy, and endoscopic ultrasonography
to predict deep submucosal invasion in scheduled ESD patients
Scientific Title:Acronym
Comparison of NBI, chromoendoscopy, and endoscopic ultrasonography
to predict deep submucosal invasion in scheduled ESD patients
Region
| Asia(except Japan) |
Condition
Condition
Colorectal ESD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary end point was accuracy for prediction of depth of invasion and histology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the accuracy for the prediction of depth of invasion and histology of superficial colorectal tumor before C-ESD
Key secondary outcomes
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
patients with superficial colorectal tumor detected during previous colonoscopy
Key exclusion criteria
morphologically advanced colorectal cancer,coexistence of advanced cancer,previously diagnosed with familial adenomatous polyposis, ulcerative colitis, and crohn's disease,coagulation abnormality
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Bong Min Ko |
Organization
SoonChunHyang University School of Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon
Division name
Department of Internal Medicine
Zip code
Address
SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL
+82-32-621-5094
kopa9445@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hyeon Jeong Goong |
Organization
SoonChunHyang University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL
+82-32-621-5094
Homepage URL
goong@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University Bucheon Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
We evaluated colorectal tumors by chromoencoscopy, NBI, and EUS before colorectal ESD
Management information
Registered date
| 2017 | Year | 03 | Month | 01 | Day |
Last modified on
| 2017 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030268
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
