UMIN-CTR Clinical Trial

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
Email	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
Email	kamihp3@air.ocn.ne.jp

Sponsor
Institute	Nagasaki Kamigoto Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048787