NCT06738511已完成不适用
Validation of a Molecular Signature for Early Detection of Colorectal Cancer
ADVANCED MARKER DISCOVERY S.L.4 个研究点 分布在 2 个国家目标入组 3,421 人开始时间: 2018年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,421
- 试验地点
- 4
- 主要终点
- Demonstrate the diagnosis capacity of molecular signature in plasma samples
研究概览
简要总结
The goal of this Multicentre and international prospective study is to validate a molecular signature using plasma samples in average-risk population for colorectal cancer who undergo colonoscopy in a screening setting.
The main question it aims to answer is:
Does molecular signature in plasma sample have higher diagnostic accuracy than FIT for early detection of colorectal cancer? Participants who already have a colonoscopy as part of their regular medical care for colorectal cancer screening will provide a stool sample and a plasma sample.
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
盲法说明
Laboratory Technicians
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants between the ages of 50 and 75 (both included) at the time of informed consent signed. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
- •Participants referred to the gastroenterology service who are going to undertake colonoscopy as a regular procedure for screening setting.
- •Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or older with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).
排除标准
- •Participants between the ages of 50 and 75 (both included) at the time of Informed consent signature. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
- •Participants who have been diagnosed with CRC. The diagnosis must be subsequently confirmed by biopsy or surgery and pathological anatomy analysis during the study.
结局指标
主要结局
Demonstrate the diagnosis capacity of molecular signature in plasma samples
时间窗: 48 months
次要结局
- Demonstrate superiority of molecular signature in plasma samples compared with FIT(48 months)
研究者
研究点 (4)
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