UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor; compared with that of colonoscopy(CS).
Title of the study (Brief title)	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	Hiroshi Matsumoto
Organization	Kawasaki Medical School and Hospital
Division name	Gastroenterology
Address	577 Matsushima, Kurashiki city, Okayama 710-0192, JAPAN
TEL	086-462-1111
Email	hmatsumoto0311@gmail.com

Public contact
Name of contact person	Hiroshi Matsumoto
Organization	Kawasaki Medical School and Hospital
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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