Clinical trial · Observational
Comparative Effectiveness of FITs With Colonoscopy
Comparative Effectiveness of Fecal Immunochemical Tests With Optical Colonoscopy (R01 CA215034)
- 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 preventable and/or a treatable cancer, but at least 43% of the United States population is not up-to-date with screening. Although 90% of colorectal cancer screening is done using colonoscopy, most other countries use fecal immunochemical tests, reserving colonoscopy for those with a positive fecal immunochemical test. This project will provide the foundation for a paradigm shift for colorectal cancer screening in the United States by identifying how well 5 different FITs work for detecting screening relevant neoplasia, thus reducing morbidity and mortality for colorectal cancer.
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 |
|---|---|---|---|
| Fecal immunochemical test (FIT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Fecal Immunochemical Test (FIT) Group
- description
- Each participant will complete 5 different FITs, on a single stool sample collected in a hat. Each participant will undergo optical colonoscopy and their FIT results compared with their colonoscopy with biopsy results (if applicable). We will calculate the test characteristics of each FIT.
- interventionNames
- Device: Fecal immunochemical test (FIT)
Primary outcomes (1)
- measure
- Advanced adenoma or cancer as assessed by colonoscopy with biopsy if needed
- timeFrame
- About 21 days from collection of FIT to performance of colonoscopy
- description
- Individual FIT brand results of negative, positive, or invalid
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * scheduled for a screening or surveillance colonoscopy Exclusion Criteria: * familial polyposis syndromes: ulcerative colitis or Crohn's disease: or active rectal bleeding
References
Publications (27)
- BACKGROUNDSmith RA, Andrews K, Brooks D, DeSantis CE, Fedewa SA, Lortet-Tieulent J, Manassaram-Baptiste D, Brawley OW, Wender RC. Cancer screening in the United States, 2016: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2016 Mar-Apr;66(2):96-114. doi: 10.3322/caac.21336. Epub 2016 Jan 21. PMID 26797525
- BACKGROUNDKuntz KM, Lansdorp-Vogelaar I, Rutter CM, Knudsen AB, van Ballegooijen M, Savarino JE, Feuer EJ, Zauber AG. A systematic comparison of microsimulation models of colorectal cancer: the role of assumptions about adenoma progression. Med Decis Making. 2011 Jul-Aug;31(4):530-9. doi: 10.1177/0272989X11408730. Epub 2011 Jun 14. PMID 21673186
- BACKGROUNDYoung GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, Kuipers EJ, Seaman HE. Advances in Fecal Occult Blood Tests: the FIT revolution. Dig Dis Sci. 2015 Mar;60(3):609-22. doi: 10.1007/s10620-014-3445-3. Epub 2014 Dec 10. PMID 25492500
- BACKGROUNDFedewa SA, Sauer AG, Siegel RL, Jemal A. Prevalence of major risk factors and use of screening tests for cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):637-52. doi: 10.1158/1055-9965.EPI-15-0134. PMID 25834147
- BACKGROUNDRobertson DJ, Imperiale TF. Stool Testing for Colorectal Cancer Screening. Gastroenterology. 2015 Oct;149(5):1286-93. doi: 10.1053/j.gastro.2015.05.045. Epub 2015 May 30. PMID 26033632
- BACKGROUNDAllison JE. The best screening test for colorectal cancer is the one that gets done well. Gastrointest Endosc. 2010 Feb;71(2):342-5. doi: 10.1016/j.gie.2009.10.032. No abstract available. PMID 20152313
- BACKGROUNDHawley ST, Volk RJ, Krishnamurthy P, Jibaja-Weiss M, Vernon SW, Kneuper S. Preferences for colorectal cancer screening among racially/ethnically diverse primary care patients. Med Care. 2008 Sep;46(9 Suppl 1):S10-6. doi: 10.1097/MLR.0b013e31817d932e.