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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028777
Receipt No. 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

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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
Institute Sakakibara Sapia Tower Clinic
Institute
Department

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
URL(English) https://upload.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


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