UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012129
Receipt number 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 17:49:11

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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 or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



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

Value
https://center6.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