Comparative Effectiveness of FITs With Colonoscopy

NCT ID: NCT03264898

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3761 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2023-10-01

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Fecal Immunochemical Test (FIT) Group

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.

Fecal immunochemical test (FIT)

Intervention Type: DEVICE

FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool.

Interventions

Fecal immunochemical test (FIT)

FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• scheduled for a screening or surveillance colonoscopy

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: collaborator

Barcey T. Levy

OTHER

Sponsor Role: lead

Responsible Party

Barcey T. Levy

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Barcey T Levy, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Texas Tech University Health Sciences Center

El Paso, Texas, United States

Countries

United States

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Other Identifiers

IRB ID#201610814

Identifier Type: -

Identifier Source: org_study_id