Retrospective Analysis of Colorectal Cancer Screening Results
NCT ID: NCT05374369
Last Updated: 2022-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
822 participants
OBSERVATIONAL
2022-03-29
2022-04-28
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Subjects with positive SDC2 Gene Methylation Test
Subjects must meet both of the following criteria to be eligible for the study:
1. Subjects with positive SDC2 Gene Methylation Test;
2. Subjects with colonoscopy results and/or pathological results.
SDC2 Gene Methylation Test and Q-FIT Test
Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test
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:
1. Subjects with positive Q-FIT Test;
2. Subjects with colonoscopy results and/or pathological results.
SDC2 Gene Methylation Test and Q-FIT Test
Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test
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:
1. Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test;
2. Subjects with colonoscopy results and/or pathological results.
SDC2 Gene Methylation Test and Q-FIT Test
Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test
Colonoscopy and/or pathological examination
Subjects underwent colonoscopy and/or pathological examination.
Interventions
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SDC2 Gene Methylation Test and Q-FIT Test
Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test
Colonoscopy and/or pathological examination
Subjects underwent colonoscopy and/or pathological examination.
Eligibility Criteria
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Inclusion Criteria
1. Subjects with positive SDC2 Gene Methylation Test and/or Q-FIT;
2. Subjects with colonoscopy and/or pathological results.
Exclusion Criteria
1. Data Missing or damaged;
2. Unqualified colonoscopy or unqualified stool test.
40 Years
74 Years
ALL
No
Sponsors
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Dongguan Shipai Hospital
UNKNOWN
Creative Biosciences (Guangzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhi Zhang
Role: PRINCIPAL_INVESTIGATOR
Dongguan Shipai Hospital
Locations
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Dongguan Shipai Hospital
Dongguan, Guangdong, China
Countries
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References
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Kong X, Wu Q, Zhang Z, Yu Z, Niu F, Wang X, Zou H. Effectiveness of single-target fecal DNA methylation test in regional mass screening for colorectal cancer and precancerous lesions in China. Gastroenterol Rep (Oxf). 2025 Apr 15;13:goaf029. doi: 10.1093/gastro/goaf029. eCollection 2025.
Other Identifiers
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KLM2021-03
Identifier Type: -
Identifier Source: org_study_id
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