UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008001 |
|---|---|
| Receipt number | R000009404 |
| Scientific Title | Diagnostic ability of CT colonography obtained by dual energy CT with fecal tagging for polypoid lesions in the colon |
| Date of disclosure of the study information | 2012/05/21 |
| Last modified on | 2015/05/21 09:21:27 |
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Basic information
Public title
Diagnostic ability of CT colonography obtained by dual energy CT with fecal tagging for polypoid lesions in the colon
Acronym
Diagnostic ability of dual energy CT colonography
Scientific Title
Diagnostic ability of CT colonography obtained by dual energy CT with fecal tagging for polypoid lesions in the colon
Scientific Title:Acronym
Diagnostic ability of dual energy CT colonography
Region
| Japan |
Condition
Condition
colon cancer, adenoma, polyp
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate diagnostic ability of CT colonography by dual energy CT for polypoid colonic lesions compared with diagnosis by colonoscopy as a golden standard
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of the diagnosis by dual energy CT colonography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
CT colonography
colonoscopy
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
Patients with fecal occult blood positive including patients with colonic lesion present or unknown.
In both cases, CTC obervers will be blinded to the colonoscopy results and other medical records
Key exclusion criteria
Patients with contraindication of either colonoscopy or CT colonograhy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norinari Honda |
Organization
Postgradute School, Saitama Medical University
Division name
Department of Radiology at Kawagoe
Zip code
Address
1981 Kamoda, Kawagoe, Saitama
TEL
0492283439
norihnd@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norinari Honda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Radiology
Zip code
Address
1981 Kamoda, kawagoe, Saitama
TEL
049-228-34.39
Homepage URL
norihnd@saitama-med.ac.jp
Sponsor or person
Institute
Postgraduate School, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Postgraduate School, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
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
埼玉医科大学総合医療センター
放射線科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | 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 | 21 | Day |
Last modified on
| 2015 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009404
