Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,002
- 试验地点
- 11
- 主要终点
- Specificity of the InterVenn test
研究概览
简要总结
The NICE study is a prospective, multi-site study to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications
详细描述
InterVenn is using its glycoprotein profiling technology platform that couples high-resolution liquid chromatography (LC)-mass spectrometry (MS) with an artificial intelligence (AI), neural network (NN)-based high-throughput data processing software to identify patterns uniquely associated with colon adenoma and colon adenocarcinoma in order to detect (pre)cancerous events early. The purpose of this prospective multi-center observational study is to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between the ages of 45-
- •Able to provide an informed consent and who understand and agree to all study procedures required
- •Subject is scheduled or will soon be scheduled to receive a colonoscopy as ordered by their doctor.
排除标准
- •Any active malignancy
- •Any other illness that in the opinion of the investigator, makes the subject not a good candidate for the study.
结局指标
主要结局
Specificity of the InterVenn test
时间窗: up to 90 days from baseline
To determine the specificity of the InterVenn test
Sensitivity of the InterVenn test
时间窗: up to 90 days from baseline
To determine the sensitivity of the InterVenn test
次要结局
未报告次要终点