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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007850
Receipt No. R000009252
Scientific Title Clinical usefulness of endocytoscopy for colorectal serrated polyps
Date of disclosure of the study information 2012/04/27
Last modified on 2012/04/27

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Basic information
Public title Clinical usefulness of endocytoscopy for colorectal serrated polyps
Acronym Clinical usefulness of endocytoscopy for colorectal serrated polyps
Scientific Title Clinical usefulness of endocytoscopy for colorectal serrated polyps
Scientific Title:Acronym Clinical usefulness of endocytoscopy for colorectal serrated polyps
Region
Japan

Condition
Condition Accurate endoscopic criteria to differentiate the family of serrated polyps including hyperplastic polyp (HP), sessile serrated adenoma/polyp (SSA/P), and traditional serrated adenoma (TSA) is needed because of the progression of them to carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine the endocytoscopic feature of serrated polyps focusing on elements of the shape of crypts and nuclei with endocytoscope.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy of each endocytoscpic criteria to diagnose colorectal serrated polyps
Key secondary outcomes

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 endocytoscopic examination for colorectal serrated lesions
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 lesions which were pathologically diagnosed as serrated polyps
Key exclusion criteria # polyps diameter less than 5mm
# polyps not observed with EC
# polyps with carcinoma component
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MAKOTO KUTSUKAWA
Organization Showa University Nothern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Showa University Nothern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
Homepage URL
Email

Sponsor
Institute Digestive Disease Center, Showa University Nothern 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 昭和大学横浜市北部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 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 Open public recruiting
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 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
2012 Year 04 Month 27 Day
Last modified on
2012 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009252

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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