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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 822

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan Shipai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with positive SDC2 Gene Methylation Test; 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; 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.
Subjects with positive Q-FIT Test; 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; 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.
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: 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Creative Biosciences (Guangzhou) Co., Ltd.
• Collaborators: Dongguan Shipai Hospital
• Investigators: Principal Investigator: Zhi Zhang, Dongguan Shipai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Colonoscopy; Colon Cancer; FIT; Cancer Screening; Fecal Immunochemical Test; Stool DNA test; Fecal DNA test; Methylation Biomarkers
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: KLM2021-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No