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.
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.
Study Type
OBSERVATIONAL
Enrollment
6,000
Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.
Binzhou Medical University Hospotal
Binzhou, Shandong, China
RECRUITINGPeople's Hospital of Lixia District of Jinan
Jinan, Shandong, China
RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
The accuracy of us-qFIT to diagnose colorectal advanced adenoma.
The sensitivity, specificity, positive predictive value and negative predictive value.
Time frame: 24 months
The accuracy of us-qFIT to diagnose colorectal cancer.
The sensitivity, specificity, positive predictive value and negative predictive value.
Time frame: 24 months
The accuracy of us-qFIT to diagnose high-risk adenoma.
The sensitivity, specificity, positive predictive value and negative predictive value.
Time frame: 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.
Time frame: 24 months
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Weihai Municipal Hospital
Weihai, Shandong, China
RECRUITINGShanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGTianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITING