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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Occult Blood Test | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 kind of FOBT and colonoscopy with pathological examination | Diagnostic Test | Detect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination. |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of 4 kind of FOBTs to diagnose CRC. | The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC. | 6 months |
| The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm. | The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm. | 6 months |
| The accuracy of 4 kind of FOBTs to diagnose advanced adenoma. | The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma. | 6 months |
| Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT. | Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the cost-benefit ratio of one or two-sample of qFIT. | Explore the cost-benefit ratio of one or two-sample of qFIT. | 6 month |
| Explore the reason of false positive of qFIT | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria from Qilu Hospital were enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li, PhD | Qilu Hospital of Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital | Jinan | Shandong | 250001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27769517 | Background | Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Apr;152(5):1217-1237.e3. doi: 10.1053/j.gastro.2016.08.053. Epub 2016 Oct 19. | |
| 41714770 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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Stool sample
| 6 month |
| Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT | Count sensitivity and specificity with or without patients who take aspirin or other anticoagulants. | 6 month |
| Derived |
| Mirza IA, Meng FY, Han Z, Wang PZ, Li YY, Zhang Y, Ma MJ, Zuo XL, Li YQ, Zhou RC. Risk factors associated with false-positive fecal immunochemical test results in colorectal cancer screening. Sci Rep. 2026 Feb 19;16(1):9794. doi: 10.1038/s41598-026-40251-w. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |