UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002299 |
|---|---|
| Receipt number | R000002805 |
| Scientific Title | Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor; compared with that of colonoscopy(CS). |
| Date of disclosure of the study information | 2009/08/11 |
| Last modified on | 2018/09/08 12:13:27 |
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Basic information
Public title
Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor; compared with that of colonoscopy(CS).
Acronym
Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor.
Scientific Title
Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor; compared with that of colonoscopy(CS).
Scientific Title:Acronym
Evaluation of accuracy of computed tomographic colonography (CTC, virtual colonoscopy) for colorectal tumor.
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
| Laboratory medicine | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to evaluation of accuracy of computed tomography (CTC; virtual colonoscopy) against colorectal tumor, compared with optical colonoscopy(CS).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of detection ability of CTC, compared with that of optical colonoscopy.
Key secondary outcomes
The difference of ability of CTC by pre-examination treatments.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CTC and CS
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 have already diagnosed in colorectal tumor by CS.
2.Signed informed consent 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
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Matsumoto |
Organization
Kawasaki Medical School and Hospital
Division name
Gastroenterology
Zip code
Address
577 Matsushima, Kurashiki city, Okayama 710-0192, JAPAN
TEL
086-462-1111
hmatsumoto0311@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Matsumoto |
Organization
Kawasaki Medical School and Hospital
Division name
Gastroenterology
Zip code
Address
577 Matsushima, Kurashiki city, Okayama 710-0192, JAPAN
TEL
086-462-1111
Homepage URL
hmatsumoto0311@gmail.com
Sponsor or person
Institute
Kawasaki Medical School and Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 08 | Month | 11 | 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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 05 | Day |
Last modified on
| 2018 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002805
