Retrospective Analysis of Colorectal Cancer Screening Results

NCT05374369 | Completed

• 1 other identifier: KLM2021-03
• Study Type: observational
• Target: 822
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Colorectal Cancer; Colon Cancer; Stool DNA test; Fecal DNA test; Fecal Immunochemical Test; FIT; Methylation Biomarkers; Colonoscopy; Cancer Screening

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Subjects with positive SDC2 Gene Methylation 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.

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

Subjects with positive 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.

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

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.

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

Interventions

SDC2 Gene Methylation Test and Q-FIT Test DIAGNOSTIC_TEST

Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test

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

Colonoscopy and/or pathological examination PROCEDURE

Subjects underwent colonoscopy and/or pathological examination.

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

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects live in Shipai Town, Dongguan city, the age limit is 40-74 years，822 subjects meet the inclusion criteria for this study.

You may qualify if:

• 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.

You may not qualify if:

• Subject with any of the following conditions shall be excluded:
• Data Missing or damaged;
• Unqualified colonoscopy or unqualified stool test.

Sponsors & Collaborators

• Creative Biosciences (Guangzhou) Co., Ltd.: lead
• Dongguan Shipai Hospital: collaborator

Study Sites (1)

Dongguan Shipai Hospital

Dongguan, Guangdong, China

Location

Related Publications (1)

• Kong X, Wu Q, Zhang Z, Yu Z, Niu F, Wang X, Zou H. Effectiveness of single-target fecal DNA methylation test in regional mass screening for colorectal cancer and precancerous lesions in China. Gastroenterol Rep (Oxf). 2025 Apr 15;13:goaf029. doi: 10.1093/gastro/goaf029. eCollection 2025.

  PMID: 40241850 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Digestive System Neoplasms; Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zhi Zhang

  Dongguan Shipai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: March 29, 2022
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-03

Locations

CN (1)