A Comparison of Quantitative Fecal Immunochemical Test and Qualitative Fecal Occult Blood Test for Colorectal Cancer Screening in Medium and High Risk Screening Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Shandong University
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- The accuracy of 4 kind of FOBTs to diagnose CRC.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. The purpose of this study is to compare the accuracy of 4 different fecal occult blood testing in medium and high risk screening population in Chinese.
Detailed Description
Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number of cancer-associated mortality. CRC screening has been shown to be effective in reducing the incidence of, and mortality from, CRC. There are several recommended screening options for screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT) .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced colorectal neoplasia but also has several disadvantages, including higher cost and poorer compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in screening population of CRC in Chinese. To add to the evidence on FIT performance characteristics for detection of CRC, the investigators design this research to compare qFIT with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them is chemical and immunologic combined detection）in medium and high risk screening population.
Investigators
Yanqing Li
Clinical Professor
Shandong University
Eligibility Criteria
Inclusion Criteria
- •Adults 50-75 years old;
- •Asia-Pacific Colorectal Screening score(APCS): medium or high risk.
Exclusion Criteria
- •APCS score: low risk;
- •People with history of intestinal surgery;
- •People with history of CRC;
- •People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
- •People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea and Bristol feces score 7th type;
- •Pregnancy, lactation or menstrual phase;
- •Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
Outcomes
Primary Outcomes
The accuracy of 4 kind of FOBTs to diagnose CRC.
Time Frame: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.
The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.
Time Frame: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT.
Time Frame: 6 months
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.
The accuracy of 4 kind of FOBTs to diagnose advanced adenoma.
Time Frame: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.
Secondary Outcomes
- Explore the reason of false positive of qFIT(6 month)
- Explore the cost-benefit ratio of one or two-sample of qFIT.(6 month)
- Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT(6 month)