Clinical trial · Interventional
Japanese National Computed Tomographic (CT) Colonography Trial
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
NCT00997802CI-TRIAL-00026501JANCTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Colonic Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT colonography and optical colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CT colonography and optical colonoscopy
- interventionNames
- Device: CT colonography and optical colonoscopy
Primary outcomes (1)
- measure
- sensitivity in the detection of colorectal polyps and cancers in CTC
- timeFrame
- 1.5 years
Secondary outcomes (1)
- measure
- specificity and predictive values in the detection of colorectal polyps and cancers in CTC.
- timeFrame
- 1.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (1)
- RESULTNagata 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 27779195