CRC 检测 可靠的血液评估 (CRC-DRAW)
用于结直肠癌血基筛查的下一代试验临床验证的前瞻性多中心观察研究
The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
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California
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Chula Vista、California、美国、91910
- Gastro SB
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San Diego、California、美国、92123
- Medical Associates Research Group
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San Diego、California、美国、92103
- SDG Clinical Research
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
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Previous personal history of CRC or precancerous lesions
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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
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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
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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
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Diagnosed with chronic gastritis or cirrhosis
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Current diagnosis of any cancer, except non-melanoma skin cancer
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Overt rectal bleeding or bleeding hemorrhoids within previous 30 days
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A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation
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Pregnancy
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Next-Gen CRC Screening Test
Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy |
The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensitivity for CRC of the Next-Gen CRC Screening Test
大体时间:blood collection up to 90 days from colonoscopy
|
Clinical Performance |
blood collection up to 90 days from colonoscopy
|
|
Specificity for CRC of the Next-Gen CRC Screening Test
大体时间:blood collection up to 90 days from colonoscopy
|
Clinical Performance |
blood collection up to 90 days from colonoscopy
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test
大体时间:blood collection up to 90 days from colonoscopy
|
Clinical Performance |
blood collection up to 90 days from colonoscopy
|
|
Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test
大体时间:blood collection up to 90 days from colonoscopy
|
Clinical Performance |
blood collection up to 90 days from colonoscopy
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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