Status:
COMPLETED
Japanese National Computed Tomographic (CT) Colonography Trial
Lead Sponsor:
Japanese CT Colonography Society
Conditions:
Colonic Polyps
Colonic Neoplasms
Eligibility:
All Genders
20+ years
Phase:
NA
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 ...
Detailed Description
The investigators will evaluate the sensitivity of CTC in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (CRC), using opti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
1257 Patients enrolled
Trial Details
Trial ID
NCT00997802
Start Date
October 1 2009
End Date
January 1 2017
Last Update
March 17 2017
Active Locations (12)
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1
Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Otarukyokai Hospital
Otaru, Hokkaido, Japan, 047-8510
3
Tonan Hospital
Sapporo, Hokkaido, Japan, 060-0001
4
Hokkaido Social Insurance Hospital
Sapporo, Hokkaido, Japan, 062-8618