Comparative Effectiveness of FITs With Colonoscopy

NCT03264898 | Completed

• 1 other identifier: IRB ID#201610814
• Study Type: observational
• Target: 3,761
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Advanced adenoma or cancer as assessed by colonoscopy with biopsy if needed

  Individual FIT brand results of negative, positive, or invalid

  About 21 days from collection of FIT to performance of colonoscopy

Study Arms (1)

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.

Device: Fecal immunochemical test (FIT)

Interventions

Fecal immunochemical test (FIT) DEVICE

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

Fecal Immunochemical Test (FIT) Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being scheduled for screening or surveillance colonoscopies meeting the study criteria at three academic health centers

You may qualify if:

• scheduled for a screening or surveillance colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Barcey T. Levy: lead
• University of North Carolina: collaborator
• Texas Tech University Health Sciences Center: collaborator

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79924, United States

Location

Related Publications (26)

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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.

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• Daly JM, Xu Y, Crockett SD, Hoffman RM, Levy BT. Is Cognitive Impairment Associated with Inadequate Bowel Preparation for Colonoscopy? J Am Board Fam Med. 2025 Sep 15;38(3):423-430. doi: 10.3122/jabfm.2024.240338R1.

  PMID: 40789626 DERIVED

• Levy BT, Xu Y, Daly JM, Hoffman RM, Dawson JD, Shokar NK, Zuckerman MJ, Molokwu J, Reuland DS, Crockett SD. Comparative Performance of Common Fecal Immunochemical Tests : A Cross-Sectional Study. Ann Intern Med. 2024 Oct;177(10):1350-1360. doi: 10.7326/M24-0080. Epub 2024 Sep 3.

  PMID: 39222513 DERIVED

• Daly JM, Xu Y, Crockett SD, Schmidt ME, Kim P, Levy BT. Clock-Drawing Test as a Screening Tool for Cognitive Impairment Associated With Fecal Immunochemical Test Collection Errors. Ann Fam Med. 2022 Sep-Oct;20(5):452-459. doi: 10.1370/afm.2855.

  PMID: 36228064 DERIVED

• Levy BT, Daly JM, Xu Y, Crockett SD, Hoffman RM, Dawson JD, Parang K, Shokar NK, Reuland DS, Zuckerman MJ, Levin A. Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol. Contemp Clin Trials. 2021 Jul;106:106430. doi: 10.1016/j.cct.2021.106430. Epub 2021 May 8.

  PMID: 33974994 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Barcey T Levy, PhD, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 29, 2017
• Study Start: October 2, 2017
• Primary Completion: March 7, 2023
• Study Completion: October 1, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Once study key publications have been accepted and finalized for publication.
• Access Criteria: Researchers have to make a formal proposal for data and codebook.

Locations

US (3)