UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of accuracy of computed tomographic colonography (CTC) in the diagnosis of colorectal tumor by gastroenterologists and radiologists with computer-aided detection (CAD): A multicenter study
Title of the study (Brief title)	Japanese National CT Colonography Trial
Region	Japan

Condition
Condition	colorectal cancer, colorectal polyp
Classification by specialty	Gastroenterology Radiology Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To address the accuracy of CT colonography (CTC) in detecting colorectal polyps and cancers in subjects at increased risk of colorectal cancer, using optical colonoscopy as the reference standard. This clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (CAD). In addition, this study will compare diagnostic performance between radiologists and gastroenterologists.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	CTC vs. optical colonoscopy. Detection performance and accuracy of colorectal polyps (at least 6 mm in diameter) and colorectal cancer.
Key secondary outcomes	The differences of detection performance of human readings without and with CAD. Diagnostic performances between radiologists and gastroenterologists. Comparative adherence of patients to CTC and optical colonoscopy. Frequency and nature of any adverse events.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	CTC and optical 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Outpatients who are eligible for optical colonoscopy. 2) Aged 20 years or older. 3) Major functions of organs of the subjects are in a good condition. 4) Signed informed consent forms are obtained by the patients.
Key exclusion criteria	1) Known colorectal polyps or cancers at any site at the time of enrollment. 2) Patients with inflammatory bowel disease. 3) Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria). 4) Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit. 5) Previous colorectal surgery. 6) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon. 7) Evidence of an increased risk in carrying out bowel preparation or CTC exams. 8) Possibility of pregnancy. 9) Optical colonoscopy or barium enema carried out within the last 3 years. 10) Patients with psychological conditions that contraindicate colonoscopy or make them irrelevant to participate in the trial. 11) Iodine hypersensitivity. 12) Severe thyroid disease. 13) Claustrophobia. 14) Severe deafness. 15) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size	1500

Research contact person
Name of lead principal investigator	Koichi Nagata
Organization	Massachusetts General Hospital and Harvard Medical School
Division name	3D Imaging Laboratory, Department of Radiology
Address	25 New Chardon St., Suite 400C, Boston, MA 02114, USA
TEL	+1-617-643-4321
Email	ctc_trial@live.jp

Public contact
Name of contact person	Koichi Nagata
Organization	Massachusetts General Hospital and Harvard Medical School
Division name	3D Imaging Laboratory, Department of Radiology
Address	25 New Chardon St., Suite 400C, Boston, MA 02114, USA
TEL	+1-617-643-4321
Homepage URL
Email	ctc_trial@live.jp

Sponsor
Institute	Japanese CTC Society
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Showa University Northern Yokohama Hospital
Name of secondary funｄer(s)	Aze, Ltd. Horii Pharmaceutical Ind., Ltd. CancerScan Co., Ltd.

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT00997802
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北海道社会事業協会小樽病院（北海道）、北海道消化器科病院（北海道）、北海道社会保険病院（北海道）、秋田赤十字病院（秋田県）、自治医科大学附属病院（栃木県）、自治医科大学附属さいたま医療センター（埼玉県）、聖路加国際病院（東京都）、東京女子医科大学東医療センター（東京都）、浜松南病院（静岡県）、藤田保健衛生大学坂文種報徳會病院（愛知県）、長崎県　上五島病院（長崎県）、金沢大学附属病院（石川県）、川崎医科大学附属病院（岡山県）、KKR札幌医療センター　斗南病院（北海道）、マサチューセッツ総合病院・ハーバードメディカルスクール（アメリカ合衆国　マサチューセッツ州）

Other administrative information
Date of disclosure of the study information	2009 Year 06 Month 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 06 Month 12 Day
Anticipated trial start date	2009 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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.nature.com/ajg/journal/vaop/ncurrent/pdf/ajg2016478a.pdf
Results
Other related information

Management information
Registered date	2009 Year 06 Month 20 Day
Last modified on	2016 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002534