Japanese National Computed Tomographic (CT) Colonography Trial

Completed · Not applicable

Conditions studied: Colonic Polyps, Colonic Neoplasms

In brief

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.

Key facts

Study ID

NCT00997802

Run by

Japanese CT Colonography Society

People needed

1257

Starts

2009-10-01

Expected to finish

2017-01-01

Last updated by the study team

2017-03-17

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital — Boston, Massachusetts, United States
• Otarukyokai Hospital — Otaru, Hokkaido, Japan
• Tonan Hospital — Sapporo, Hokkaido, Japan
• Hokkaido Social Insurance Hospital — Sapporo, Hokkaido, Japan
• Hokkaido Gastroenterology Hospital — Sapporo, Hokkaido, Japan
• Kanazawa University Hospital — Kanazawa, Ishikawa-ken, Japan
• Showa University Northern Yokohama Hospital — Yokohama, Kanagawa, Japan
• Kamigoto Hospital — Kamigotō, Nagasaki, Japan
• Kawasaki Medical School — Kurashiki, Okayama-ken, Japan
• Hamamatsu South Hospital — Hamamatsu, Shizuoka, Japan
• Jichi Medical University Hospital — Shimono, Tochigi, Japan
• Tokyo Women's Medical University Medical Center East — Arakawa-ku, Tokyo, Japan

Full record on ClinicalTrials.gov

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