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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005085
Receipt No. R000006045
Scientific Title Magnifying chromoscopic colonoscopy versus endoscopic ultrasonography to predict depth of invasion for early colorectal cancer
Date of disclosure of the study information 2011/02/16
Last modified on 2014/01/18

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Basic information
Public title Magnifying chromoscopic colonoscopy versus endoscopic ultrasonography to predict depth of invasion for early colorectal cancer
Acronym Magnifying colonoscopy vs. EUS to predict depth of invasion for early colorectal cancer
Scientific Title Magnifying chromoscopic colonoscopy versus endoscopic ultrasonography to predict depth of invasion for early colorectal cancer
Scientific Title:Acronym Magnifying colonoscopy vs. EUS to predict depth of invasion for early colorectal cancer
Region
Japan

Condition
Condition Patients with early colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare accuracy of the invasion depth for early colorectal cancer between magnifying chromoscopic colonoscopy (MC) and EUS
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy rate for invasion depth of early colorectal cancer by MC and EUS
Key secondary outcomes Sensitivity and specificity for deep submucosal invasion, Observation time, Accuracy rate betweeen MC in A group and EUS in B group, Accuracy rate in each group between MC and EUS

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 "A group: MC followed by EUS" for diagnosis of invasion depth
From February 2011 to December 2013
Interventions/Control_2 "B group: EUS followed by MC" for diagnosis of invasion depth
From February 2011 to December 2013
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically confirmed adenocarcinoma
2.Early colorectal cancer with flat type
3.Less than 4cm in size
4.20 years old =< age =< 90 years old
5.PS:0-2
6.Written informed consent
Key exclusion criteria 1.Patients with strong anticoagulant therapy
2.Severe heart, lung and renal dysfunction
3.Severe constipation
4.Weak patients who can not be treated by endoscopy or surgery
5.Investigator's decision
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shimura Takaya
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shimura Takaya
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8211
Homepage URL
Email

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya Daini Red Cross Hospital
Chukyo Hospital
Gifu Prefectural Tajimi Hospital
Nagoya Memorial Hospital
kasugai Municipal Hospital
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 名古屋市立大学病院(愛知県)、名古屋第二赤十字病院(愛知県)、社会保険中京病院(愛知県)、岐阜県立多治見病院(岐阜県)、名古屋記念病院(愛知県)、春日井市民病院(愛知県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S1542356513010343
Number of participants that the trial has enrolled
Results
MC and EUS each measured the depth of lesion invasion with 71.2% accuracy (correctly for 47 of 66 lesions).
MC and EUS are equally accurate in estimating the invasion depth of early stage CRC lesions.
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
2011 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2013 Year 01 Month 31 Day
Date of closure to data entry
2013 Year 02 Month 28 Day
Date trial data considered complete
2013 Year 02 Month 28 Day
Date analysis concluded
2013 Year 03 Month 21 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 15 Day
Last modified on
2014 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006045

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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