Colorectal Cancer Clinical Trial
Official title:
Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .
Status | Not yet recruiting |
Enrollment | 275 |
Est. completion date | April 20, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - People who use the new instrument for fecal immunochemical test(FIT) - People sign an "informed consent form" Exclusion Criteria: - People with history of surgery in any part of the large bowel; - People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score); |
Country | Name | City | State |
---|---|---|---|
China | Qilu Hospital | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic performance of advanced neoplasms | The study is committed to test the diagnostic efficacy of the new instrument to advanced neoplasms.We will measure the sensitivity and specificity of the instrument | 4 months | |
Secondary | Diagnostic performance of Colorectal Cancer | The study is committed to test the diagnostic efficacy of the new instrument to colorectal cancer.We will measure the sensitivity and specificity of the instrument | 4 months |
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