UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014939 |
|---|---|
| Receipt number | R000017382 |
| Scientific Title | Analysis of the surface microvascular patterns of colorectal lesions by endocytoscopy |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2015/08/16 17:55:11 |
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Basic information
Public title
Analysis of the surface microvascular patterns of colorectal lesions by endocytoscopy
Acronym
Microvascular patterns observed by endocytoscopy
Scientific Title
Analysis of the surface microvascular patterns of colorectal lesions by endocytoscopy
Scientific Title:Acronym
Microvascular patterns observed by endocytoscopy
Region
| Japan |
Condition
Condition
colorectal lesions
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of present pilot study was to research ultra-magnified microvessels findings of colorectal lesions and to evaluate their diagnostic ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The diagnostic ability of ultra-magnified microvessel pattern for predicting histopathology of colorectal lesions.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Lesions observed by magnifying Endocytoscopy
2.Over 20 years old
3.Written informed consent
Key exclusion criteria
1) taking antiplatelet or anticoagulant
2) inflammatory bowel disease patients
Following lesions were excluded from this study
a. advanced cancer (T2 or more),
b. neuroendocrine tumor
c. non-epithelial tumor
d. sessile serrated adenoma / polyp (SSA/P).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Misawa |
Organization
Showa University, Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL
045-949-7265
misawaanny@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Misawa |
Organization
Showa University, Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL
045-949-7265
Homepage URL
misawaanny@ybb.ne.jp
Sponsor or person
Institute
Showa University, Northern Yokohama 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
| 2014 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.giejournal.org/article/S0016-5107(15)02399-8/abstract
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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was retrospective study.
Management information
Registered date
| 2014 | Year | 08 | Month | 24 | Day |
Last modified on
| 2015 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017382
