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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05374369
Other study ID # KLM2021-03
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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