Retrospective Analysis of Colorectal Cancer Screening Results

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374369
• Other study ID #: KLM2021-03
• Status: Completed
• Start date: March 29, 2022
• Est. completion date: April 28, 2022

Study information

• Verified date: March 2022
• Source: Creative Biosciences (Guangzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 822
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Dongguan Shipai Hospital	Dongguan	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Creative Biosciences (Guangzhou) Co., Ltd.	Dongguan Shipai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Sensitivity	Sensitivity is the percentage of subjects with colon cancer who are correctly identified by the testing kit.	one month
Primary	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