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Recruitment status Completed
Unique ID issued by UMIN UMIN000014393
Receipt No. R000016750
Scientific Title Study of the usefulness 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

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Basic information
Public title Study of the usefulness of novel pit structure associated with type IVv pit pattern for colorectal tumor :Pilot study
Acronym Novelpit structure associated with type IVv pit pattern
Scientific Title Study of the usefulness of novel pit structure associated with type IVv pit pattern for colorectal tumor :Pilot study
Scientific Title:Acronym Novelpit structure associated with type IVv pit pattern
Region
Japan

Condition
Condition colorectal lesions
Classification by specialty
Gastroenterology
Classification by malignancy Others
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 Exploratory
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Magnified endoscopy
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 magnified endoscopy.
Key exclusion criteria (1)Advanced colorectal cancer(T2 or more)
Target sample size 70

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
Email 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
Email yasuharumaeda610@hotmail.com

Sponsor
Institute Showa University, Northern Yokohama Hospital
Institute
Department

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
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
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
Date analysis concluded

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016750

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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