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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) .
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Immunochemical Test | People in this group will detect hemoglobin in stool before colonoscopy by the new instrument |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The new instrument and colonoscopy with pathological examination | Diagnostic Test | Detect hemoglobin in stool by the point-of-care testing instrument before colonoscopy, detect colon lesion using colonoscopy and pathological examination. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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People who use the new instrument for Fecal Immunochemical Test.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song yihao, BD | Contact | 15098739370 | 1019038804@qq.com | |
| Zhou ruchen, MD | Contact | 15949702165 | sdlwzrc@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li yanqing, Professor | Qilu Hospital of Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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stool samples
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |