Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)
试验速览
- 阶段
- 不适用
- 入组人数
- 4,500
- 试验地点
- 6
- 主要终点
- The difference in test specificity between initial testing and repeat testing 1 year
研究概览
简要总结
This study will evaluate longitudinal performance of Epi proColon with respect to test positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up colonoscopy and diagnostic yield, as well as assay failure rates.
详细描述
Epi proColon is blood based screening test for colorectal cancer that is FDA - PMA approved. It is indicated for average risk patients who are unwilling or unable to be screened with other recommended screening tests, including colonoscopy or fecal occult blood tests.
The PERT study is designed to assess the test performance of Epi proColon when it is used annually for two consecutive years. Subjects enrolled in the study will be offered initial testing. Subjects with a positive result will be referred for colonoscopy. Subjects with a negative test result will be encouraged to be screened the following year. At the one year interval, test negative subjects will be reminded to be rescreened. Subjects with a positive test will be referred for colonoscopy, while subjects with a negative test will be be encouraged to participate in a screening program in subsequent years.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Average-risk subjects (no family history of colorectal cancer (CRC), no personal history of polyps or CRC).
- •Subjects who have a history of non-compliance for CRC screening.
- •After proper counseling by a health care provider, subjects who declined colonoscopy and FIT testing.
- •Subjects who are 50 years of age or greater, but less than 75 years old.
- •Subjects who are able to understand and sign written informed consent (IC).
排除标准
- •Subjects defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD).
- •Subjects with a family history of CRC, particularly with two or more first degree relatives with CRC, or one or more first degree relative(s) less than 50 years of age with CRC.
- •Subjects who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as familial adenomatous polyposis (FAP) or non-polyposis colorectal cancer (HNPCC or Lynch Syndrome), 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, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.
- •Subjects who are up to date for CRC screening (FOBT within preceding 12 months, flexible sigmoidoscopy or double contrast barium enema within 5 years, or colonoscopy within 10 years).
- •Subjects with comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years).
- •Subjects with chronic gastritis, or who have cancer other than colorectal, or pregnant women.
结局指标
主要结局
The difference in test specificity between initial testing and repeat testing 1 year
时间窗: Through study completion, expected at 60 months
* Subjects will be tested with blood-based Epi proColon assay at initial enrollment, and tested again 1 year later (positive or negative test results) * Subjects with positive test results with Epi proColon assay are referred to colonoscopy. Colonoscopy outcomes will be recorded (no evidence of disease or CRC) * The difference in test specificity between initial and follow-up visits will be recorded.
Detection of colorectal cancer
时间窗: Through study completion, expected at 60 months
Findings of colorectal cancer in subjects with a colonoscopy following a positive Epi proColon test will be recorded.
次要结局
- Adherence to testing(Through study completion, expected at 60 months)
- Diagnostic Yield(Through study completion, expected at 60 months)
- Adherence to colonoscopy(Through study completion, expected at 60 months)
- Assay Failure Rate(Through study completion, expected at 60 months)