The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,600
- 试验地点
- 28
- 主要终点
- Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient)
研究概览
简要总结
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.
详细描述
OBJECTIVES:
Primary
- Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia.
Secondary
- Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations.
- Determine the effects of different colon preparations on the accuracy of CTC in these participants.
- Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy.
- Determine the accuracy of CTC in detecting flat lesions in the colon of these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient)
时间窗: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=9mm (as measured at pathology) RS-: No Advanced adenomas \>=9mm found by colonoscopy (as measured at pathology)
Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient)
时间窗: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=7mm (as measured at pathology) RS-: No Advanced adenomas \>=7mm found by colonoscopy (as measured at pathology)
Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient)
时间窗: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=10mm (as measured at pathology) RS-: No Advanced adenomas \>=10mm found by colonoscopy (as measured at pathology)
Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient)
时间窗: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=8mm (as measured at pathology) RS-: No Advanced adenomas \>=8mm found by colonoscopy (as measured at pathology)
Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient)
时间窗: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=5mm (as measured at pathology) RS-: No Advanced adenomas \>=5mm found by colonoscopy (as measured at pathology)
Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient)
时间窗: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=6mm (as measured at pathology) RS-: No Advanced adenomas \>=16mm found by colonoscopy (as measured at pathology)
次要结局
- Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion)(within 30 days)
- Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion)(within 30 days)
- Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion)(within 30 days)
- Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion)(within 30 days)
- Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion)(within 30 days)
- Interobserver Sensitivity Variability(at baseline)
- Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion)(within 30 days)