Japanese National Computed Tomographic (CT) Colonography Trial
JANCT
Evaluation of Accuracy of Computed Tomographic Colonography (CTC) in the Diagnosis of Colorectal Tumors by Gastroenterologists and Radiologists With Computer-aided Detection (CAD): A Multicenter Study
1 other identifier
interventional
1,257
2 countries
12
Brief Summary
The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 18, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMarch 17, 2017
March 1, 2017
6.2 years
October 18, 2009
March 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensitivity in the detection of colorectal polyps and cancers in CTC
1.5 years
Secondary Outcomes (1)
specificity and predictive values in the detection of colorectal polyps and cancers in CTC.
1.5 years
Study Arms (1)
CT colonography and optical colonoscopy
OTHERInterventions
All patients will undergo CT colonography and optical colonoscopy.
Eligibility Criteria
You may qualify if:
- Outpatients who are eligible for optical colonoscopy.
- Aged 20 years or older.
- Major functions of organs of the subjects are in a good condition.
- Signed informed consent forms are obtained from the patients.
You may not qualify if:
- Known colorectal polyps or cancers at any site at the time of enrollment.
- Patients with inflammatory bowel disease.
- Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
- Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
- Previous colorectal surgery.
- Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
- Evidence of an increased risk in carrying out bowel preparation or CTC exams.
- Possibility of pregnancy.
- Optical colonoscopy or barium enema carried out within the last 3 years.
- Patients with psychological conditions that contraindicate colonoscopy or that make them irrelevant to participate in the trial.
- Iodine hypersensitivity.
- Severe thyroid disease.
- Claustrophobia.
- Severe deafness.
- Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Otarukyokai Hospital
Otaru, Hokkaido, 047-8510, Japan
Tonan Hospital
Sapporo, Hokkaido, 060-0001, Japan
Hokkaido Social Insurance Hospital
Sapporo, Hokkaido, 062-8618, Japan
Hokkaido Gastroenterology Hospital
Sapporo, Hokkaido, 065-0041, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503, Japan
Kamigoto Hospital
Kamigotō, Nagasaki, 857-4404, Japan
Kawasaki Medical School
Kurashiki, Okayama-ken, 701-0192, Japan
Hamamatsu South Hospital
Hamamatsu, Shizuoka, 430-0846, Japan
Jichi Medical University Hospital
Shimono, Tochigi, 329-0498, Japan
Tokyo Women's Medical University Medical Center East
Arakawa-ku, Tokyo, 116-8567, Japan
Related Publications (1)
Nagata K, Endo S, Honda T, Yasuda T, Hirayama M, Takahashi S, Kato T, Horita S, Furuya K, Kasai K, Matsumoto H, Kimura Y, Utano K, Sugimoto H, Kato H, Yamada R, Yamamichi J, Shimamoto T, Ryu Y, Matsui O, Kondo H, Doi A, Abe T, Yamano HO, Takeuchi K, Hanai H, Saida Y, Fukuda K, Nappi J, Yoshida H. Accuracy of CT Colonography for Detection of Polypoid and Nonpolypoid Neoplasia by Gastroenterologists and Radiologists: A Nationwide Multicenter Study in Japan. Am J Gastroenterol. 2017 Jan;112(1):163-171. doi: 10.1038/ajg.2016.478. Epub 2016 Oct 25.
PMID: 27779195RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Koichi Nagata, MD, PhD
Japanese CTC Society
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- 3D Imaging Laboratory, Massachusetts General Hospital
Study Record Dates
First Submitted
October 18, 2009
First Posted
October 19, 2009
Study Start
October 1, 2009
Primary Completion
December 11, 2015
Study Completion
January 1, 2017
Last Updated
March 17, 2017
Record last verified: 2017-03