N/A
N=2,600
The National CT Colonography Trial
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00084929 ↗Enrolled (actual)
2,600
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) — 109; 2422 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CT Colonography (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- American College of Radiology Imaging Network
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) |
109; 2422 | — |
| PRIMARY Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) |
120; 2411 | — |
| PRIMARY Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) |
154; 2377 | — |
| PRIMARY Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) |
174; 2357 | — |
| PRIMARY Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) |
210; 2321 | — |
| PRIMARY Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) |
282; 2249 | — |
| SECONDARY Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) |
108; 20 | — |
| SECONDARY Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) |
117; 26 | — |
| SECONDARY Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) |
149; 38 | — |
| SECONDARY Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) |
165; 55 | — |
| SECONDARY Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) |
189; 81 | — |
| SECONDARY Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) |
221; 153 | — |
| SECONDARY Interobserver Sensitivity Variability |
0.94; 0.88 | — |
Summary
RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.
PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
Eligibility Criteria
- Inclusion Criteria
- Male or female outpatients
- Aged 50 years or older
- Scheduled for screening colonoscopy
- Participant's signed informed consent
- Exclusion Criteria
- Symptoms of disease of the lower gastrointestinal tract, including
- Melanotic stools or/and hematochezia on more than one occasion in the previous six months
- Lower abdominal pain that would normally require a medical evaluation
- Inflammatory bowel disease and/or familial polyposis syndrome
- Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit
- Pregnancy
- Previous colonoscopy within the past five years
- Anemia (hemoglobin less than 10 gm/dl)
- Positive fecal occult blood test (FOBT)
Data sourced from ClinicalTrials.gov (NCT00084929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.