Retrospective Analysis of Colorectal Cancer Screening Results

Creative Biosciences

Status: Completed

Conditions: Digestive System Neoplasm; Neoplasms; Hyperplastic Polyp; Colorectal Neoplasms; Advanced Adenocarcinoma; Colorectal Cancer

Treatments: Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test; Procedure: Colonoscopy and/or pathological examination

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05374369

KLM2021-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 822 patients

Sex: All

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

822 participants in 3 patient groups

Subjects with positive SDC2 Gene Methylation Test

Description:

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.

Treatment:

Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test

Procedure: Colonoscopy and/or pathological examination

Subjects with positive Q-FIT Test

Description:

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.

Treatment:

Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test

Procedure: Colonoscopy and/or pathological examination

Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test

Description:

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.

Treatment:

Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test

Procedure: Colonoscopy and/or pathological examination