Comparative Effectiveness of FITs With Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Comparative Effectiveness of Fecal Immunochemical Tests With Optical Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264898
• Other study ID #: R01CA215034
• Status: Recruiting
• Start date: October 2, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2018
• Source: University of Iowa
• Contact: Barcey T Levy, PhD, MD
• Phone: 319-384-7000
• Email: barcey-levy[@]uiowa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer death in both men and women in the U.S., with nearly 50,000 deaths each year. Since CRC develops over a number of years from precursor lesions called polyps, it is largely detectable and preventable in early stages. As these polyps become larger, they, like most CRCs, tend to bleed, which is the rationale for the use of fecal occult blood tests (FOBTs) to detect both polyps and cancers early, while they are curable. However, early screening and detection is much less common than it could be, with about 43% of eligible individuals unscreened. Fecal immunochemical tests (FITs) are a type of FOBT that can be a sensitive, specific, and low cost alternative to colonoscopy for CRC screening. Modeling studies have shown that for population screening, a strategy of annual FIT testing from age of 50 to 75 years results in an equal number of life-years gained as compared with colonoscopy every 10 years. However, about 90% of screening in the U.S. is done with colonoscopy, the most expensive and invasive screening test. FITs are far less costly and largely replacing the guaiac test in CRC screening programs internationally, where only individuals with positive results are referred for a colonoscopy. Studies done on FITs in other countries often used FITs not available in the U.S. or studied high-risk populations; thus, results are not applicable in the U.S. It is critical to determine the FIT(s) with the best test characteristics in order to implement successful FIT-based screening programs in this country.

It is estimated that 24 million more individuals will need to be screened by 2018 to reach the "80% by 2018" goal set by the National Colorectal Cancer Roundtable. To address this knowledge gap, investigators propose to compare the test characteristics of three Clinical Laboratory Improvement Amendments (CLIA)-waived FITs and two automated FITs, using colonoscopy as the gold standard. The rationale for this proposed study is that, for almost all of the FITs currently marketed in the U.S., there is no evidence of the accuracy claimed. Specific aims are: Aim 1: To assess the diagnostic accuracy for advanced colorectal neoplasms of three of the most commonly used CLIA-waived FITs and two automated FITs, using colonoscopy as the gold standard.

Aim 2: To evaluate the diagnostic accuracy of two quantitative FITs using receiver operating characteristic (ROC) analysis. Aim 3: To assess factors associated with false positive and false negative FIT results for each device.

These findings will provide essential information about FITs with the best test characteristics for future expanded use of FIT, critically important to achieving the long-term goal of reducing morbidity and mortality from CRC. FITs are more acceptable to patients, will allow higher screening rates, and will reduce costs as compared with a screening strategy based on colonoscopy as the primary initial screening method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• scheduled for a screening or surveillance colonoscopy

Exclusion Criteria:

• familial polyposis syndromes: ulcerative colitis or Crohn's disease: or active rectal bleeding

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• Fecal immunochemical test (FIT)
FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	University of Iowa	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
University of Iowa	Texas Tech University Health Sciences Center, University of North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (22)

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Crouse AL, De Koning L, Sadrzadeh SM, Naugler C. Sensitivity and Specificity of Community Fecal Immunotesting Screening for Colorectal Carcinoma in a High-Risk Canadian Population. Arch Pathol Lab Med. 2015 Nov;139(11):1441-5. doi: 10.5858/arpa.2014-0454-OA. — View Citation

de Wijkerslooth TR, Stoop EM, Bossuyt PM, Meijer GA, van Ballegooijen M, van Roon AH, Stegeman I, Kraaijenhagen RA, Fockens P, van Leerdam ME, Dekker E, Kuipers EJ. Immunochemical fecal occult blood testing is equally sensitive for proximal and distal advanced neoplasia. Am J Gastroenterol. 2012 Oct;107(10):1570-8. doi: 10.1038/ajg.2012.249. Epub 2012 Jul 31. — View Citation

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Levi Z, Rozen P, Hazazi R, Vilkin A, Waked A, Maoz E, Birkenfeld S, Lieberman N, Klang S, Niv Y. Sensitivity, but not specificity, of a quantitative immunochemical fecal occult blood test for neoplasia is slightly increased by the use of low-dose aspirin, NSAIDs, and anticoagulants. Am J Gastroenterol. 2009 Apr;104(4):933-8. doi: 10.1038/ajg.2009.14. Epub 2009 Mar 17. — View Citation

Levy BT, Bay C, Xu Y, Daly JM, Bergus G, Dunkelberg J, Moss C. Test characteristics of faecal immunochemical tests (FIT) compared with optical colonoscopy. J Med Screen. 2014 Sep;21(3):133-43. doi: 10.1177/0969141314541109. Epub 2014 Jun 23. — View Citation

Robertson 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. Review. — View Citation

Rozen P, Comaneshter D, Levi Z, Hazazi R, Vilkin A, Maoz E, Birkenfeld S, Niv Y. Cumulative evaluation of a quantitative immunochemical fecal occult blood test to determine its optimal clinical use. Cancer. 2010 May 1;116(9):2115-25. doi: 10.1002/cncr.25012. — View Citation

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Wolf RL, Basch CE, Brouse CH, Shmukler C, Shea S. Patient preferences and adherence to colorectal cancer screening in an urban population. Am J Public Health. 2006 May;96(5):809-11. Epub 2006 Mar 29. — View Citation

Xu Y, Levy BT, Daly JM, Bergus GR, Dunkelberg JC. Comparison of patient preferences for fecal immunochemical test or colonoscopy using the analytic hierarchy process. BMC Health Serv Res. 2015 Apr 23;15:175. doi: 10.1186/s12913-015-0841-0. — View Citation

Young 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. Review. — View Citation

Zauber AG, Lansdorp-Vogelaar I, Knudsen AB, Wilschut J, van Ballegooijen M, Kuntz KM. Evaluating test strategies for colorectal cancer screening: a decision analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Nov 4;149(9):659-69. Epub 2008 Oct 6. — View Citation

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Zavoral M, Suchanek S, Zavada F, Dusek L, Muzik J, Seifert B, Fric P. Colorectal cancer screening in Europe. World J Gastroenterol. 2009 Dec 21;15(47):5907-15. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIT Result	Individual FIT results of negative, positive, or invalid	From recruitment of first subject through study completion, an average of 4 years

External Links

•   National Colorectal Cancer Roundtable. Tools & Resources - 80% by 2018