NCT06059963招募中不适用
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 45-84 years at time of consent
- •Intended to undergo a standard-of-care screening colonoscopy
- •Considered by a physician or healthcare provider as being of 'average risk' for CRC
- •Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.
- •Willing to consent to follow-up for one year as per protocol
- •Able and willing to sign informed consent
排除标准
- •Undergoing colonoscopy for investigation of CRC risk symptoms
- •Has undergone colonoscopy within preceding 9 years
- •Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
- •Has completed Cologuard or Epi proColon testing within the previous 3 years.
- •Has undergone a CT colonography in the prior 4 years.
- •History of colorectal cancer.
- •History of any malignancy within prior 5 years.
- •Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
- •Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age <60 years or with more than one first-degree relative diagnosed with CRC at any age.
- •Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC [HNPCC], or Familial Adenomatous Polyposis [FAP]).
- •Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
- •Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- •Known pregnancy at informed consent, blood sample collection, and during study participation.
- •Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy.
结局指标
主要结局
Primary Objective
时间窗: 1 year
The primary objective of this study is to determine the sensitivity for CRC and specificity for advanced neoplasia (AN). Advance Neoplasia (AN) is defined as a final diagnosis of CRC or Advanced Precancerous Lesion (APL).
次要结局
- Secondary Objective(1 year)
研究者
研究点 (1)
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