Clinical trial NCT05374369: Retrospective Analysis of Colorectal Cancer Screening Results
Official title: Retrospective Analysis of Colorectal Cancer Screening Results Among People Aged 40-74 in Shipai Town, Dongguan City, China
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Creative Biosciences (Guangzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Dongguan Shipai Hospital
First posted: 2022-05-16
Enrollment: 822
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positive predictive value (PPV)
timeFrame: one month
measure: Sensitivity
timeFrame: one month
measure: Tumor detection rate in the positive screening results
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan Shipai Hospital
state: Guangdong
Study officials:
affiliation: Dongguan Shipai Hospital
name: Zhi Zhang
role: PRINCIPAL_INVESTIGATOR
References: