Clinical trial · Observational
A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening
A Comparison of Quantitative Fecal Immunochemical Test and Qualitative Fecal Occult Blood Test for Colorectal Cancer Screening in Medium and High Risk Screening Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4 kind of FOBT and colonoscopy with pathological examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Fecal Occult Blood Test
- description
- 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.
- interventionNames
- Diagnostic Test: 4 kind of FOBT and colonoscopy with pathological examination
Primary outcomes (4)
- measure
- The accuracy of 4 kind of FOBTs to diagnose CRC.
- timeFrame
- 6 months
- description
- The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.
- measure
- The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.
- timeFrame
- 6 months
- description
- The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDRobertson 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. PMID 27769517
- DERIVEDMirza 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. PMID 41714770