Retrospective Analysis of Colorectal Cancer Screening Results

Completed

• Conditions: Hyperplastic Polyp; Digestive System Neoplasm; Colorectal Neoplasms; Neoplasms; Colorectal Cancer; Advanced Adenocarcinoma
• Interventions: Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test; Procedure: Colonoscopy and/or pathological examination

• Registration Number: NCT05374369
• Lead Sponsor: Creative Biosciences (Guangzhou) Co., Ltd.

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.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-29
• Primary Completion: 2022-04-28
• Study Completion: 2022-04-28
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 822

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with positive Q-FIT Test	Colonoscopy and/or pathological examination	Subjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive Q-FIT Test; 2. Subjects with colonoscopy results and/or pathological results.
Subjects with positive SDC2 Gene Methylation Test	SDC2 Gene Methylation Test and Q-FIT Test	Subjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive SDC2 Gene Methylation Test; 2. Subjects with colonoscopy results and/or pathological results.
Subjects with positive SDC2 Gene Methylation Test	Colonoscopy and/or pathological examination	Subjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive SDC2 Gene Methylation Test; 2. Subjects with colonoscopy results and/or pathological results.
Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test	SDC2 Gene Methylation Test and Q-FIT Test	Subjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test; 2. Subjects with colonoscopy results and/or pathological results.
Subjects with positive Q-FIT Test	SDC2 Gene Methylation Test and Q-FIT Test	Subjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive Q-FIT Test; 2. Subjects with colonoscopy results and/or pathological results.
Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test	Colonoscopy and/or pathological examination	Subjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test; 2. Subjects with colonoscopy results and/or pathological results.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dongguan Shipai Hospital; 🇨🇳 Dongguan, Guangdong, China