Colorectal Cancer Clinical Trial
Official title:
Retrospective Analysis of Colorectal Cancer Screening Results Among People Aged 40-74 in Shipai Town, Dongguan City, China
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 |
Verified date | March 2022 |
Source | Creative Biosciences (Guangzhou) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Dongguan Shipai Hospital | Dongguan | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Creative Biosciences (Guangzhou) Co., Ltd. | Dongguan Shipai Hospital |
China,
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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