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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034549
Receipt No. 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 2018/10/17

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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
Middle name
Last name Kotaro Shibagaki
Organization Faculty of Medicine, Shimane University
Division name gastroenterology
Zip code
Address 89-1 Enya, Izumo, Japan
TEL +81-85320-2190
Email kotaro@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Shibagaki
Organization Faculty of Medicine, Shimane University
Division name gastroenterology
Zip code
Address 89-1 Enya, Izumo, Japan
TEL +81-85320-2190
Homepage URL
Email kotaro@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

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
Address
Tel
Email

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
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
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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