NCT05374369

Retrospective Analysis of Colorectal Cancer Screening Results

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 822 (actual)
• Sponsor: Creative Biosciences (Guangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Advanced Adenocarcinoma
• Hyperplastic Polyp
• Colorectal Neoplasms
• Digestive System Neoplasm
• Neoplasms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SDC2 Gene Methylation Test and Q-FIT Test	Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test
PROCEDURE	Colonoscopy and/or pathological examination	Subjects underwent colonoscopy and/or pathological examination.

Timeline

• Start date: 2022-03-29
• Primary completion: 2022-04-28
• Completion: 2022-04-28
• First posted: 2022-05-16
• Last updated: 2022-07-29

Locations

1 site across 1 country: China