UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028777
Receipt number R000032877
Scientific Title Evaluation for the patient acceptance of CT colonography
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/22 19:13:50

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Basic information

Public title

Evaluation for the patient acceptance of CT colonography

Acronym

Evaluation for the patient acceptance of CT colonography

Scientific Title

Evaluation for the patient acceptance of CT colonography

Scientific Title:Acronym

Evaluation for the patient acceptance of CT colonography

Region

Japan


Condition

Condition

Healthy individual

Classification by specialty

Gastroenterology Radiology Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Identify the factors associated with patient discomfort of CT colonography

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Patient acceptance

Key secondary outcomes

Patient intention for future screening


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy individual.
2. Major functions of organs of the subjects are in a good condition.
3. Signed informed consent forms are obtained by the patients.

Key exclusion criteria

1. Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
2. Evidence of an increased risk in carrying out bowel preparation or CTC exams.
3. Possibility of pregnancy.
4. Patients with psychological conditions that contraindicate CT colonography or make them irrelevant to participate in the trial.
5. Claustrophobia.
6. Iodine hypersensitivity.
7. Severe thyroid disease.
8. Severe deafness.
9. Subjects whose eligibility for this clinical trial is not appropriate by other reasons.

Target sample size

1800


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Nagata M.D Ph.D.

Organization

National Cancer Center

Division name

Division of Screening Technology, Center for Public Health Science

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045 Japan

TEL

03-3542-2511

Email

Nagata7@aol.com


Public contact

Name of contact person

1st name
Middle name
Last name Kayoko Kasuya

Organization

National Cancer Center

Division name

Division of Medical Support and Partnership,Center for Cancer Control and Information Services

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045 Japan

TEL

03-3542-2511

Homepage URL


Email

kkasuya@ncc.go.jp


Sponsor or person

Institute

Sakakibara Sapia Tower Clinic

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Cancer Center

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

2017 Year 09 Month 01 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

No longer recruiting

Date of protocol fixation

2010 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date

2017 Year 08 Month 31 Day

Date of closure to data entry

2017 Year 10 Month 01 Day

Date trial data considered complete

2017 Year 10 Month 15 Day

Date analysis concluded

2017 Year 10 Month 31 Day


Other

Other related information

We evaluate the patient characteristics associated with discomfort for CT colonography.
The basic patient characteristics are as follows: age, gender, BMI, history of pelvic or abdominal surgery, previous experience of other colorectal examinations.


Management information

Registered date

2017 Year 08 Month 22 Day

Last modified on

2017 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032877


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name