Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer

Study Overview
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Brief Summary
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Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.

Detailed Description
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Early detection of CRC in a curable stage can reduce mortality but not morbidity. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost. Conversely, stool tests are relatively cheap and more readily accepted. Fecal immunochemical test (FIT) is economic and easy to use in colorectal cancer screening. However, the common used qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve the detection rate of colorectal advanced adenoma, Ultra-sensitivity quantitative fecal immunochemical test (us-qFIT) improves technology and can detect fecal hemoglobin in extremely low concentration quantificationally. The investigators design this research to prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenoma.

Official Title
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Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study

Conditions
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Colorectal Neoplasm

Intervention / Treatment
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* Diagnostic Test: The us-qFIT and colonoscopy with pathological examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50-75 years old people; People sign an informed consent form Exclusion Criteria: People with history of colorectal surgery; People with history of colorectal cancer; People with history of other diseases that may produce fecal blood, such as inflammatory bowel disease, ischemic enteritis, vascular alformation of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive tract; People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and watery stool; People are in pregnancy, lactation or menstrual phase; People with severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Us-qFIT group<br>People in this group will detect fecal hemoglobin concentration by us-qFIT before colonoscopy. | Diagnostic Test: The us-qFIT and colonoscopy with pathological examination<br>* Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of us-qFIT to diagnose colorectal advanced adenoma. | The sensitivity, specificity, positive predictive value and negative predictive value. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of us-qFIT to diagnose colorectal cancer. | The sensitivity, specificity, positive predictive value and negative predictive value. | 24 months | 
| The accuracy of us-qFIT to diagnose high-risk adenoma. | The sensitivity, specificity, positive predictive value and negative predictive value. | 24 months | 
| Develop a predictive model of advanced colorectal neoplasms which includes the value of us-qFIT. | Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history, diet and so on. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenoma, Colorectal Neoplasm, Occult Bleeding, Quantitative fecal immunochemical test, Colorectal Cancer