UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002097 |
|---|---|
| Receipt number | 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 16:36:24 |
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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
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
ctc_trial@live.jp
Sponsor or person
Institute
Japanese CTC Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002534
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