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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002097
Receipt No. R000002534
Scientific Title 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
Date of disclosure of the study information 2009/06/20
Last modified on 2016/11/07

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Basic information
Public title 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
Acronym Japanese National CT Colonography Trial
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Koichi Nagata
Organization Massachusetts General Hospital and Harvard Medical School
Division name 3D Imaging Laboratory, Department of Radiology
Zip code
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
1st name
Middle name
Last name Koichi Nagata
Organization Massachusetts General Hospital and Harvard Medical School
Division name 3D Imaging Laboratory, Department of Radiology
Zip code
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.

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nature.com/ajg/journal/vaop/ncurrent/pdf/ajg2016478a.pdf
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 Main results already published
Date of protocol fixation
2009 Year 06 Month 12 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000002534

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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