Advanced Adenocarcinoma, Colorectal Cancer, Colorectal Neoplasms, Digestive System Neoplasm, Hyperplastic Polyp, Neoplasms
Conditions
Keywords
Colorectal Cancer, Colon Cancer, Stool DNA test, Fecal DNA test, Fecal Immunochemical Test, FIT, Methylation Biomarkers, Colonoscopy, Cancer Screening
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSDC2 Gene Methylation Test and Q-FIT Test
Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test
PROCEDUREColonoscopy and/or pathological examination
Subjects underwent colonoscopy and/or pathological examination.
Sponsors
Dongguan Shipai Hospital
Creative Biosciences (Guangzhou) Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive SDC2 Gene Methylation Test and/or Q-FIT; 2. Subjects with colonoscopy and/or pathological results.
Exclusion criteria
Subject with any of the following conditions shall be excluded: 1. Data Missing or damaged; 2. Unqualified colonoscopy or unqualified stool test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value (PPV) | 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 | 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 | one month | Compare to clinical standard method results, the tumor detection rates of the three groups were analyzed. |
Countries
China
Outcome results
None listed