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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002299
Receipt No. R000002805
Scientific Title Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor; compared with that of colonoscopy(CS).
Date of disclosure of the study information 2009/08/11
Last modified on 2018/09/08

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Basic information
Public title Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor; compared with that of colonoscopy(CS).
Acronym Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor.
Scientific Title Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor; compared with that of colonoscopy(CS).
Scientific Title:Acronym Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor.
Region
Japan

Condition
Condition Colorectal tumor
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Laboratory medicine Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Aim of this study is to evaluation of accuracy of computed tomography (CTC; virtual colonoscopy) against colorectal tumor, compared with optical colonoscopy(CS).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of detection ability of CTC, compared with that of optical colonoscopy.
Key secondary outcomes The difference of ability of CTC by pre-examination treatments.
Adherence of patient with CTC
Frequency of adverse events

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 CTC and CS

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.Patients who have already diagnosed in colorectal tumor by CS.
2.Signed informed consent forms are obtained by the patients
Key exclusion criteria 1.Patients who be with serious medical condition by any disease.
2.Subjects whose eligibility for this trial is not appropriate by other reasons.
3. Evidence of increased risk in carrying CS or contrast CT.
4. Evidence of increased risk of bowel perforation by CTC exam.
a. deep colonic ulcers including toxic megacolon
b. intestinal stenosis, obstraction,
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School and Hospital
Division name Gastroenterology
Zip code
Address 577 Matsushima, Kurashiki city, Okayama 710-0192, JAPAN
TEL 086-462-1111
Email hmatsumoto0311@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School and Hospital
Division name Gastroenterology
Zip code
Address 577 Matsushima, Kurashiki city, Okayama 710-0192, JAPAN
TEL 086-462-1111
Homepage URL
Email hmatsumoto0311@gmail.com

Sponsor
Institute Kawasaki Medical School and Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2009 Year 08 Month 11 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 Completed
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 05 Day
Last modified on
2018 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002805

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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