Retrospective Analysis of Colorectal Cancer Screening Results

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retrospective Analysis of Colorectal Cancer Screening Results Among People Aged 40-74 in Shipai Town, Dongguan City, China

Conditions
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Colorectal Cancer, Advanced Adenocarcinoma, Hyperplastic Polyp, Colorectal Neoplasms, Digestive System Neoplasm, Neoplasms

Intervention / Treatment
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* Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test
* Procedure: Colonoscopy and/or pathological examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Subject with any of the following conditions shall be excluded: Data Missing or damaged; Unqualified colonoscopy or unqualified stool test.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with positive SDC2 Gene Methylation Test<br>Subjects must meet both of the following criteria to be eligible for the study: Subjects with positive SDC2 Gene Methylation Test; Subjects with colonoscopy results and/or pathological results. | Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test<br>* Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test<br>Procedure: Colonoscopy and/or pathological examination<br>* Subjects underwent colonoscopy and/or pathological examination.<br>|
| Subjects with positive Q-FIT Test<br>Subjects must meet both of the following criteria to be eligible for the study: Subjects with positive Q-FIT Test; Subjects with colonoscopy results and/or pathological results. | Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test<br>* Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test<br>Procedure: Colonoscopy and/or pathological examination<br>* Subjects underwent colonoscopy and/or pathological examination.<br>|
| Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test<br>Subjects must meet both of the following criteria to be eligible for the study: Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test; Subjects with colonoscopy results and/or pathological results. | Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test<br>* Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test<br>Procedure: Colonoscopy and/or pathological examination<br>* Subjects underwent colonoscopy and/or pathological examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value (PPV) | PPV is the number of real positive cases in the total number of stool gene DNA methylation detection positive or/and Q-FIT positive. | one month | 
| Sensitivity | Sensitivity is the percentage of subjects with colon cancer who are correctly identified by the testing kit. | one month | 
| Tumor detection rate in the positive screening results | Compare to clinical standard method results, the tumor detection rates of the three groups were analyzed. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Colon Cancer, Stool DNA test, Fecal DNA test, Fecal Immunochemical Test, FIT, Methylation Biomarkers, Colonoscopy, Cancer Screening