UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	CT colonography, Visceral Fat Analysis, Adiponectin and Colorectal tumor risk
Title of the study (Brief title)	CT colonography, Visceral Fat Analysis, Adiponectin and Colorectal tumor risk
Region	Japan

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

Objectives
Narrative objectives1	Aim of this study is to evaluation of relationship among CT colonograhy, Visceral Fat Analysis, Adiponectin for Colorectal tumor risk
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of relationship of CT colonograhy, Visceral Fat Analysis, Adiponectin for Colorectal tumor risk
Key secondary outcomes	The finding rate of extra-colon disease at CT colonography 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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	CT colonography
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 need to have abdominal CT examination 2.Signed informed 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	160

Research contact person
Name of lead principal investigator	Hiroshi Matsumoto
Organization	Kawasaki Medical School
Division name	Gastroenterology
Address	577 Matsushima, Kurashiki city, Okayama, JAPAN
TEL	086-462-1111
Email	hmatsumoto0311@gmail.com

Public contact
Name of contact person	Hiroshi Matsumoto
Organization	Kawasaki Medical School
Division name	Gastroenterology
Address	Matsushima 577, Kurashiki city, Okayama, JAPAN
TEL	086-462-1111
Homepage URL
Email	hmatsumoto0311@gmail.com

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JAPAN

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	川崎医科大学附属病院（岡山県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry	2017 Year 11 Month 05 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 26 Day
Last modified on	2017 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006696