UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008009 |
|---|---|
| Receipt number | R000009418 |
| Scientific Title | Fundamental and clinical research for CT colonography enforcement. |
| Date of disclosure of the study information | 2012/05/22 |
| Last modified on | 2012/05/22 10:28:56 |
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Basic information
Public title
Fundamental and clinical research for CT colonography enforcement.
Acronym
Fundamental and clinical reseach of CT colonography.
Scientific Title
Fundamental and clinical research for CT colonography enforcement.
Scientific Title:Acronym
Fundamental and clinical reseach of CT colonography.
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to evaluation of acciracy of computed tomography (CTC;virtual colonoscopy) against colonoscopy tumor,compared with optical colonoscopy(CS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of detection ability of CTC,compared with that of potical colonoscopy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The inspection by CT colonography
Interventions/Control_2
The inspection by colonoscopy
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 coloretal 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 forthis trial is not appropriate by other reasons.
3.Evidence of increased risk in carrying CS or 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
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Ymashita |
Organization
Tokyo examination-for-cancer center
Division name
Radiology
Zip code
Address
2-9-2musashidai,fucyu city,Tokyo 183-0042,JAPAN
TEL
042-327-0201
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukako Inahara |
Organization
Tokyo examination-for-cancer center
Division name
Radiology
Zip code
Address
2-9-2musashidai,fucyu city,Tokyo 183-0042,JAPAN
TEL
042-327-0201
Homepage URL
Sponsor or person
Institute
Tokyo examination-for-cancer center
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
| 2012 | Year | 05 | Month | 22 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 22 | Day |
Last modified on
| 2012 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009418
