A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening
- Conditions
- Colorectal Cancer
- Interventions
- Diagnostic Test: 4 kind of FOBT and colonoscopy with pathological examination
- Registration Number
- NCT04454099
- Lead Sponsor
- Shandong University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- Adults 50-75 years old;
- Asia-Pacific Colorectal Screening score(APCS): medium or high risk.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fecal Occult Blood Test 4 kind of FOBT and colonoscopy with pathological examination People in this group will use four kind of fecal occult blood test, including quantitative and qualitative method, to detect Hb in stool before colonoscopy.
- Primary Outcome Measures
Name Time Method The accuracy of 4 kind of FOBTs to diagnose CRC. 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. 6 months The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.
The accuracy of 4 kind of FOBTs to diagnose advanced adenoma. 6 months The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT. 6 months Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.
- Secondary Outcome Measures
Name Time Method Explore the reason of false positive of qFIT 6 month Calculate false positive rate of the 4 kind of FOBTs. and count the case number of inflammatory bowel disease, colonic diverticulitis, hemorrhoids, upper gastrointestinal disease or medical factors that cause false positive of qFIT.
Explore the cost-benefit ratio of one or two-sample of qFIT. 6 month Explore the cost-benefit ratio of one or two-sample of qFIT.
Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT 6 month Count sensitivity and specificity with or without patients who take aspirin or other anticoagulants.
Trial Locations
- Locations (1)
Qilu Hospital
🇨🇳Jinan, Shandong, China