Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Natera, Inc.
- 入组人数
- 25,000
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
The FIND-CRC study is a prospective collection of samples and data from participants who are at average risk of developing colorectal cancer (CRC). Collected samples and data will be analyzed to evaluate the clinical performance of the Natera CRC Screening Test.
详细描述
Participants who meet study inclusion criteria will be invited to enroll in the study and will provide written consent prior to study procedures. Participants will provide blood samples and will be required to have a colonoscopy performed within 120 days of their blood draw. No test results from the blood collection will be provided to participants or clinicians.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent.
- •40 years of age or older at the time of consent.
- •Planning or intending to undergo a standard of care colonoscopy.
- •Able to tolerate venipuncture for research draw(s).
- •Able and willing to provide blood samples within the 120 days prior to a standard-of-care pre-bowel preparation procedure and colonoscopy procedure.
- •Willing and able to comply with the study visit schedule and study requirements.
排除标准
- •Any prior history of any kind of malignancy (exception: participants who have undergone surgical removal of skin squamous cell or basal cell cancers may be enrolled, provided the procedure was completed at least 12 months prior to consent for the study).
- •Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.
- •Undergoing diagnostic colonoscopy for the investigation of symptoms.
- •Up to date with colorectal cancer screening from any non-invasive test.
- •Precancerous findings on most recent colonoscopy.
- •Had a prior colorectal resection for any reason other than sigmoid diverticular disease.
- •Known personal history of any of the following high-risk conditions:
- •7a. Inflammatory bowel disease. 7b. Known hereditary condition that would increase risk of colorectal cancer (example Lynch Syndrome).
结局指标
主要结局
Primary Outcome
时间窗: 24 months
The primary outcomes of this study are sensitivity of the Natera CRC Screening Test for the detection of colorectal cancer (CRC) and specificity of the test for advanced neoplasia (AN), as assessed by agreement of the Natera CRC Screening test with colonoscopy findings.
次要结局
- Secondary Outcomes(24 months)