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NCT Number: NCT05374369

Retrospective Analysis of Colorectal Cancer Screening Results

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.

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Key information

Conditions

Colorectal Cancer Advanced Adenocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasm Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hyperplastic Polyp Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongguan Shipai Hospital

Dongguan, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Subject with any of the following conditions shall be excluded:

  • Data Missing or damaged;
  • Unqualified colonoscopy or unqualified stool test.

Treatment and study plan

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

Colonoscopy and/or pathological examination

Procedure

Subjects underwent colonoscopy and/or pathological examination.

Primary outcomes

  1. Positive predictive value (PPV)

    Time frame: one month

    PPV is the number of real positive cases in the total number of stool gene DNA methylation detection positive or/and Q-FIT positive.

  2. Sensitivity

    Time frame: one month

    Sensitivity is the percentage of subjects with colon cancer who are correctly identified by the testing kit.

  3. Tumor detection rate in the positive screening results

    Time frame: one month

    Compare to clinical standard method results, the tumor detection rates of the three groups were analyzed.

Sponsors and collaborators

Lead sponsor

Creative Biosciences (Guangzhou) Co., Ltd.

Industry

Collaborators

  • Dongguan Shipai Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 16, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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