Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test

Study Overview
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Brief Summary
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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) .

Detailed Description
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Colorectal cancer (CRC) is the third most common cancer worldwide and has become a progressively important public health problem that inevitably leads to an increase in morbidity and medical costs. Therefore, many countries have a screening program in place to lower the incidence of CRC. Subjects with a positive fecal immunochemical test (FIT) have a much higher likelihood of advanced neoplasms than the general population.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).

Official Title
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Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: The new instrument and colonoscopy with pathological examination


Participation Criteria
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Eligibility Criteria
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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);
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fecal Immunochemical Test<br>People in this group will detect hemoglobin in stool before colonoscopy by the new instrument | Diagnostic Test: The new instrument and colonoscopy with pathological examination<br>* Detect hemoglobin in stool by the point-of-care testing instrument before colonoscopy, detect colon lesion using colonoscopy and pathological examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |