UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034549 |
|---|---|
| Receipt number | R000038735 |
| Scientific Title | Clinical efficacy of magnification endoscopy for the diagnosis of colorectal neoplasms (a multicenter, prospective comparative study) |
| Date of disclosure of the study information | 2018/10/17 |
| Last modified on | 2020/10/18 10:32:53 |
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Basic information
Public title
Clinical efficacy of magnification endoscopy for the diagnosis of colorectal neoplasms (a multicenter, prospective comparative study)
Acronym
Clinical efficacy of magnification colonoscopy (a multicenter, prospective comparative study)
Scientific Title
Clinical efficacy of magnification endoscopy for the diagnosis of colorectal neoplasms (a multicenter, prospective comparative study)
Scientific Title:Acronym
Clinical efficacy of magnification colonoscopy (a multicenter, prospective comparative study)
Region
| Japan |
Condition
Condition
colonic polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the clinical significance of the magnification colonoscopy on the diagnosis of colorectal polyps.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy of conventional colonoscopy, maginification colonoscopy with NBI, and magnification chromoendoscopy.
Key secondary outcomes
1. Confidence level of endoscopic diagnosis witheach modality
2. Degree of reflection of JNET classification and pit pattern classification to the endoscopic diagnosis.
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
1. colonic polyps not investigated histogically.
2. patients who has a good general condition enough to undergo endoscopic procedure.
Key exclusion criteria
1. colonic lesions suspected of advanced cancer, submucosal tumor, hamartoma, inflammatory polyp, and non-epithelial tumor.
2. cases in which histologic diagnosis is difficult.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Shibagaki |
Organization
Faculty of Medicine, Shimane University
Division name
gastroenterology
Zip code
693-0032
Address
89-1 Enya, Izumo, Japan
TEL
09011848131
kotaro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | kotaro |
| Middle name | |
| Last name | Shibagaki |
Organization
Faculty of Medicine, Shimane University
Division name
gastroenterology
Zip code
693-0032
Address
89-1 Enya, Izumo, Japan
TEL
09011848131
Homepage URL
kotaro@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
No funding source
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
Shimane University
Address
89-1 Enya, Izumo, Japan
Tel
+81-85320-2190
tsubakima@jn.shimane-u.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
| 2018 | Year | 10 | Month | 17 | 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
| 2018 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is multicenter prospective study to analyze the diagnostic accuracy of colonoscopy for the colonic polyps. The endoscopic diagnosis is carried out in 3 steps; white-light endoscopy, followed by magnification endoscopy with Narrow-Band Imaging(NBIME) and magnification chromoendoscopy or NBIME with acetic acid enhancement.
Management information
Registered date
| 2018 | Year | 10 | Month | 17 | Day |
Last modified on
| 2020 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038735
| 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 |
