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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012129
Receipt No. R000006696
Scientific Title CT colonography, Visceral Fat Analysis, Adiponectin and Colorectal tumor risk
Date of disclosure of the study information 2013/10/26
Last modified on 2017/11/27

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Basic information
Public title CT colonography, Visceral Fat Analysis, Adiponectin and Colorectal tumor risk
Acronym CT colonography, Visceral Fat Analysis, Adiponectin and Colorectal tumor risk
Scientific Title CT colonography, Visceral Fat Analysis, Adiponectin and Colorectal tumor risk
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address 577 Matsushima, Kurashiki city, Okayama, 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
Division name Gastroenterology
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 08 Month 01 Day
Date of IRB
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

Other
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

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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