UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014394 |
|---|---|
| Receipt number | R000016751 |
| Scientific Title | Endocytoscopy observation of novel pit structure associated with type IVv pit pattern for colorectal tumor :Pilot study |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2018/08/14 23:49:29 |
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Basic information
Public title
Endocytoscopy observation of novel pit structure associated with type IVv pit pattern for colorectal tumor :Pilot study
Acronym
Endocytoscopy observation of novel pit structure
Scientific Title
Endocytoscopy observation of novel pit structure associated with type IVv pit pattern for colorectal tumor :Pilot study
Scientific Title:Acronym
Endocytoscopy observation of novel pit structure
Region
| Japan |
Condition
Condition
colorectal lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate if novel pit structure associated with type IVv pit pattern by magnified endoscopy or endocytoscopy can be used to predict adenoma component in colorectal lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for colorectal lesion pathology in adenoma component.
Key secondary outcomes
1) Incidence rate for novel pit structure
2) Diagnostic ability for colorectal lesion pathology in difference between cancerous and non-cancerous.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Endocytoscopy observation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Colorectal liesions with type IVv pit pattern.
(2)Colorectal liesions which were resected after observation with Endocytoscopy.
Key exclusion criteria
(1)Advanced colorectal cancer(T2 or more)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maeda Yasuharu |
Organization
Showa University, Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL
045-949-7446
yasuharumaeda610@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maeda Yasuharu |
Organization
Showa University, Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL
0459497446
Homepage URL
yasuharumaeda610@hotmail.com
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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 27 | Day |
Last modified on
| 2018 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016751
