UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042742 |
|---|---|
| Receipt number | R000048787 |
| Scientific Title | Diagnostic Performance of ultra-low dose CT Colonography for the Detection of colorectal Neoplasms. |
| Date of disclosure of the study information | 2020/12/20 |
| Last modified on | 2020/12/14 10:41:34 |
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Basic information
Public title
Diagnostic Performance of ultra-low dose CT Colonography for the Detection of colon polyps.
Acronym
Ultra-low dose CT Colonography for colon polyps.
Scientific Title
Diagnostic Performance of ultra-low dose CT Colonography for the Detection of colorectal Neoplasms.
Scientific Title:Acronym
Ultra-low dose CT Colonography for colorectal Neoplasms.
Region
| Japan |
Condition
Condition
Colorectal Neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of ultra-low dose CT Colonography for the detection of colorectal neoplasms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Per-patient performance of CT ultra low dose colonography in the detection of neoplasms, with colonoscopy results as the reference standard.
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
ultra low dose CT colonography
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who were 30 years of age or older and had abdominal symptoms such as melena or had recent positive immunochemical fecal occult blood test.
Key exclusion criteria
Those who had serious medical conditions which could increase the risk of complications associated with bowel preparation and CT Colonography, and who had colorectal polyps or cancers at any site already known at the time of enrollment, a history of inflammatory bowel disease, lynch syndrome, familial polyposis, colorectal surgery, hyperthyroidism, or iodine contrast medium allergy.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takayaki |
| Middle name | |
| Last name | Yasuda |
Organization
Nagasaki Kamigoto Hospital
Division name
Radiology
Zip code
857-4404
Address
1549-11, Shinkamigoto, Minamimatsuura, Nagasaki, Japan
TEL
0959-52-3000
kamihp3@air.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takayaki |
| Middle name | |
| Last name | Yasuda |
Organization
Nagasaki Kamigoto Hospital
Division name
Radiology
Zip code
857-4404
Address
1549-11, Shinkamigoto, Minamimatsuura, Nagasaki, Japan
TEL
0959-52-3000
Homepage URL
kamihp3@air.ocn.ne.jp
Sponsor or person
Institute
Nagasaki Kamigoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Kamigoto Hospital
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
Nagasaki Kamigoto Hospital
Address
1549-11, Shinkamigoto, Minamimatsuura, Nagasaki, Japan
Tel
0959-52-3000
kamihp3@air.ocn.ne.jp
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
| 2020 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048787
