colorectal cancer, colorectal polyp
Conditions
Interventions
Sponsors
Department od Medical Division of Radiology, Jichi Medical University
1. Otaru Kyokai Hospital
2. Hokkaido Gastroenterology Hospital
3. Tonan Hospital
4. Kameda Medical Center Makuhari
5. Kameda General Hospital
6. Matsuda Hospital
7. Kamigoto Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) fecal immunochemical test positive. 2) Major functions of organs of the subjects are in a good condition. 3) Aged 40 years or older. 4) Signed informed consent forms are obtained by the patients.
Exclusion criteria
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) Claustrophobia. 12) Iodine hypersensitivity. 13) Severe thyroid disease. 14) Severe deafness. 15) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low dose polyethylene glycol (PEG) based fecal tagging CTC vs. optical colonoscopy. Detection performance and accuracy of colorectal polyps (at least 6 mm in diameter) and colorectal cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparative adherence of patients to CTC and optical colonoscopy. Frequency and nature of any adverse events. | — |
Countries
Japan
Outcome results
None listed