UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018837 |
|---|---|
| Receipt number | R000021787 |
| Scientific Title | Diagnostic accuracy of Sessile Serrated Adenoma/Polyps(SSA/P) on magnifying Narrow Band Imaging(NBI) and biopsy diagnosis: A prospective controlled study of diagnostic accuracy |
| Date of disclosure of the study information | 2015/08/27 |
| Last modified on | 2018/04/15 14:59:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Diagnostic accuracy of Sessile Serrated Adenoma/Polyps(SSA/P) on magnifying Narrow Band Imaging(NBI) and biopsy diagnosis: A prospective controlled study of diagnostic accuracy
Acronym
Diagnostic accuracy of SSA/P on Magnifying NBI and biopsy diagnosis: A prospective controlled study of diagnostic accuracy
Scientific Title
Diagnostic accuracy of Sessile Serrated Adenoma/Polyps(SSA/P) on magnifying Narrow Band Imaging(NBI) and biopsy diagnosis: A prospective controlled study of diagnostic accuracy
Scientific Title:Acronym
Diagnostic accuracy of SSA/P on Magnifying NBI and biopsy diagnosis: A prospective controlled study of diagnostic accuracy
Region
| Japan |
Condition
Condition
Sessile serrated adenoma/polyp(SSA/P)
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compared the accuracy of endoscopic diagnosis using magnifying NBI versus biopsy diagnosis of SSA/P.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of endoscopic diagnosis using magnifying NBI and biopsy diagnosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
undergo biopsy from specimen which suspected SSA/P by endoscopic diagnosis.
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
Colorectal SSA/P 6< in diameter.
Key exclusion criteria
1) after right hemicolectomy
2) inflammatory bowel disease
3) patients whom a researcher judged to be inappropriate as a subject
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamashina Takeshi |
Organization
Osaka Red Cross Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
5-30 Fudegasaki-cho, Tennojikui-ku, Osaka, Japan
TEL
06-6774-5111
t.yamashina@osaka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamashina Takeshi |
Organization
Osaka Red Cross Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
5-30 Fudegasaki-cho, Tennojikui-ku, Osaka, Japan
TEL
06-6774-5111
Homepage URL
t.yamashina@osaka-med.jrc.or.jp
Sponsor or person
Institute
Gastroenterology and Hepatology, Osaka Red Cross Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 27 | 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 | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 27 | Day |
Last modified on
| 2018 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021787
