NCT05551052进行中（未招募）不适用
Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 196
- 试验地点
- 3
- 主要终点
- Specificity for CRC of the Next-Gen CRC Screening Test
研究概览
简要总结
The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.
详细描述
The CRC DRAW study is a prospective, multi-center, observational study to validate the Next-Gen CRC Screening test for the detection of CRC. The study will collect blood samples from average-risk participants scheduled for screening colonoscopies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 45 years of age or older at time of enrollment.
- •Participant is at average risk for development of colorectal cancer (as defined by inclusion and exclusion criteria)
- •Participant is able and willing to undergo a screening colonoscopy
- •Participant is able and willing to sign informed consent and adhere to study requirements
- •Participant is able to provide blood sample prior to colonoscopy (within 90 days of scheduled colonoscopy).
排除标准
- •Previous personal history of CRC or precancerous lesions
- •Positive result from non-invasive screening test within the associated recommended intervals:
- •2.1 Fecal occult blood test or fecal immunochemical test within the previous 12 months 2.2 Epi proColon test within the previous 12 months 2.3 FIT-DNA (Cologuard) test within the previous 36 months
- •Diagnosed with condition associated with higher risk for colorectal cancer, such as:
- •3.1 Inflammatory bowel disease (IBD) 3.2 Chronic ulcerative colitis (CUC) 3.3 Crohn's disease 3.4 Familial adenomatous polyposis (FAP) 3.5 Familial history for colorectal cancer 3.5.1 One or more first-degree relatives diagnosed with CRC or adenomatous polyps before 60 years of age 3.5.2 Two or more first degree relatives diagnosed at any age with CRC
- •Individuals with relevant familial (hereditary) cancer syndrome, such as:
- •4.1 Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome) 4.2 Peutz-Jeghers Syndrome 4.3 MYH-Associated Polyposis (MAP) 4.4 Gardner's syndrome 4.5Turcot's (or Crail's) syndrome 4.6 Cowden's syndrome, 4.7Juvenile Polyposis 4.8 Cronkhite-Canada syndrome 4.9 Neurofibromatosis 4.10 Familial Hyperplastic Polyposis
- •Diagnosed with chronic gastritis or cirrhosis
- •Current diagnosis of any cancer, except non-melanoma skin cancer
- •Overt rectal bleeding or bleeding hemorrhoids within previous 30 days
- •A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation
结局指标
主要结局
Specificity for CRC of the Next-Gen CRC Screening Test
时间窗: blood collection up to 90 days from colonoscopy
Clinical Performance
Sensitivity for CRC of the Next-Gen CRC Screening Test
时间窗: blood collection up to 90 days from colonoscopy
Clinical Performance
次要结局
- Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test(blood collection up to 90 days from colonoscopy)
- Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test(blood collection up to 90 days from colonoscopy)
研究者
研究点 (3)
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