Colorectal Neoplasm Clinical Trial
Official title:
Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study
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.
Status | Recruiting |
Enrollment | 6000 |
Est. completion date | June 30, 2023 |
Est. primary completion date | April 19, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Binzhou Medical University Hospotal | Binzhou | Shandong |
China | People's Hospital of Lixia District of Jinan | Jinan | Shandong |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | Shanghai Tongji Hospital, Tongji University School of Medicine | Shanghai | Shanghai |
China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
China | Weihai Municipal Hospital | Weihai | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University | Binzhou Medical University, People's Hospital of Lixia District of Jinan, Shanghai Tongji Hospital, Tongji University School of Medicine, Tianjin Medical University General Hospital, Weihai Municipal Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The accuracy of us-qFIT to diagnose colorectal advanced adenoma. | The sensitivity, specificity, positive predictive value and negative predictive value. | 24 months | |
Secondary | The accuracy of us-qFIT to diagnose colorectal cancer. | The sensitivity, specificity, positive predictive value and negative predictive value. | 24 months | |
Secondary | The accuracy of us-qFIT to diagnose high-risk adenoma. | The sensitivity, specificity, positive predictive value and negative predictive value. | 24 months | |
Secondary | 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 |
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---|---|---|---|
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