Multitarget Stool RNA Test (ColoSense) for Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14,263
- 试验地点
- 4
- 主要终点
- ColoSense Sensitivity for Colorectal Cancer (CRC)
研究概览
简要总结
This study was a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColoSense test, which is a multi-target stool RNA test for colorectal cancer screening.
详细描述
This phase 3 clinical trial (CRC-PREVENT) was a blinded, prospective, cross-sectional study to support a premarket approval application for a class III medical device. Subjects were recruited onto the clinical trial if they were average-risk subjects, or had a self-reported family history of CRC, aged 45 and older. All participants completed the ColoSense test, which incorporated a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status. Stool samples were collected prior to participants completing a colonoscopy at their local endoscopy center. The ColoSense test result (positive or negative) was compared with index lesions observed on colonoscopy. The primary outcomes included ColoSense sensitivity for detecting colorectal cancer, advanced adenomas, or serrated precancerous lesions, and ColoSense specificity for all other findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female, ≥45 years of age
- •Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form
- •Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure
- •Subject is able and willing to undergo a colonoscopy after providing a stool sample
排除标准
- •Subject had any precancerous finding on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in no histopathology findings are acceptable)
- •Subject has a history or diagnosis of colorectal cancer
- •Subject has a history of aerodigestive tract cancer
- •Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals:
- •Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
- •FIT-DNA test within the previous 36 months
- •Subject has had a colonoscopy in the previous nine (9) years
- •Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
- •Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
- •Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
- •Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
- •Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
- •Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome")
- •Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
结局指标
主要结局
ColoSense Sensitivity for Colorectal Cancer (CRC)
时间窗: 120 days from stool sample collection
ColoSense Sensitivity for Advanced Adenoma (AA)
时间窗: 120 days from stool sample collection
ColoSense Sensitivity for Serrated Precancerous Lesions (SPL)
时间窗: 120 days from stool sample collection
ColoSense Specificity for Negative Findings
时间窗: 120 days from stool sample collection
次要结局
未报告次要终点