NCT04144738已完成不适用
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26,758
- 试验地点
- 187
- 主要终点
- Specificity with the mt-sDNA 2.0 test
研究概览
简要总结
The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
详细描述
Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results.
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
- •Subjects must meet the following criteria to be eligible for the study:
- •Subject is ≥ 40 years of age at the time of enrollment.
- •Subject presents for a screening colonoscopy per standard of care.
- •Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- •Subject is able and willing to sign informed consent
排除标准
- •Subject has a history of CRC or advanced precancerous lesions.
- •Subject has a diagnosis or medical / family history of any of the following conditions, including:
- •Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
- •Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
- •Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
- •Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
- •Subject has a diagnosis of Cronkhite-Canada Syndrome.
- •Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
- •Subject has undergone a colonoscopy within the previous 9 years with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
- •Subject has had overt rectal bleeding within the previous 30 days.
- •Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
结局指标
主要结局
Specificity with the mt-sDNA 2.0 test
时间窗: Through study completion, an average of 180 days
Sensitivity for CRC with the mt-sDNA 2.0 test
时间窗: Through study completion, an average of 180 days
次要结局
- Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT).(Through study completion, an average of 180 days)
- Sensitivity for advanced precancerous lesions(Through study completion, an average of 180 days)
- Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT)(Through study completion, an average of 180 days)
- Specificity for no colorectal neoplastic findings(Through study completion, an average of 180 days)
研究者
研究点 (187)
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