Retrospective Analysis of Colorectal Cancer Screening Results Among People Aged 40-74 in Shipai Town, Dongguan City, China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 822
- 试验地点
- 1
- 主要终点
- Positive predictive value (PPV)
研究概览
简要总结
The purpose of this study is to retrospectively analyze colorectal cancer screening data of 40-74 year old population in Shipai Town, Dongguan City.
In this study, the data of SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) were screened from about 11,000 subjects who participated in Colorectal Cancer Screening in Shipai Town People's Livelihood Project from May 2021 to May 2022. Data from 822 subjects with positive SDC2 Gene Methylation Test and/or positive Fecal Immunochemistry Test (Q-FIT) results and with colonoscopy and/or pathological results were selected for retrospective analysis.
This retrospective study evaluated the screening performance of SDC2 Gene Methylation Test and/or Fecal Immunochemistry Test (Q-FIT) for colorectal cancer using colonoscopy and/or pathological results as the clinical standard method.
详细描述
This study is a retrospective and observational study. Subjects were not be given or offered any treatment during the study. The investigator reviewed the patient's medical history and examination report to determine eligibility based on inclusion and exclusion criteria.
This study retrospectively analyse the basic information and the test results of SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) of about 11,000 subjects who participated in the Colorectal Cancer Screening in Shipai Town People's Livelihood Project from May 2021 to May 2022. A total of 822 subjects with positive SDC2 Gene Methylation Test results and / or positive Fecal Immunochemistry Test (Q-FIT) results were screened out and their colonoscopy results were collected.
822 subjects were classified according to colonoscopy and/or pathological detection results, and the screening performance of the SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) for colorectal cancer was statistically analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet both of the following criteria to be eligible for the study:
- •Subjects with positive SDC2 Gene Methylation Test and/or Q-FIT;
- •Subjects with colonoscopy and/or pathological results.
排除标准
- •Subject with any of the following conditions shall be excluded:
- •Data Missing or damaged;
- •Unqualified colonoscopy or unqualified stool test.
结局指标
主要结局
Positive predictive value (PPV)
时间窗: one month
PPV is the number of real positive cases in the total number of stool gene DNA methylation detection positive or/and Q-FIT positive.
Sensitivity
时间窗: one month
Sensitivity is the percentage of subjects with colon cancer who are correctly identified by the testing kit.
Tumor detection rate in the positive screening results
时间窗: one month
Compare to clinical standard method results, the tumor detection rates of the three groups were analyzed.
次要结局
未报告次要终点