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Comparative Effectiveness of FITs With Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03264898
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : May 22, 2018
University of North Carolina
Texas Tech University Health Sciences Center
Information provided by (Responsible Party):
Barcey T. Levy, University of Iowa

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.

Condition or disease Intervention/treatment
Colorectal Cancer Device: Fecal immunochemical test (FIT)

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.

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Study Type : Observational
Estimated Enrollment : 3600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Fecal Immunochemical Tests With Optical Colonoscopy
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
FIT Group
Fecal immunochemical tests will be completed.
Device: Fecal immunochemical test (FIT)
FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool.

Primary Outcome Measures :
  1. FIT Result [ Time Frame: From recruitment of first subject through study completion, an average of 4 years ]
    Individual FIT results of negative, positive, or invalid

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients being scheduled for screening or surveillance colonoscopies meeting the study criteria at three academic health centers

Inclusion Criteria:

  • scheduled for a screening or surveillance colonoscopy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03264898

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Contact: Barcey T Levy, PhD, MD 319-384-7000
Contact: Jeanette M Daly, PhD 319-384-8995

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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Barcey T Levy, PhD, MD    319-384-7622   
Contact: Jeanette M Daly, PhD    319-384-8995   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Seth Crockett, MD, MPH    919-966-7151   
Contact: Dan Reuland, MD, MPH    919-966-2276   
United States, Texas
Texas Tech University Health Sciences Center Recruiting
El Paso, Texas, United States, 79924
Contact: Navkiran Shokar, MD    915-215-5574   
Contact: Marc Zuckerman, MD    915-215-5272   
Sponsors and Collaborators
University of Iowa
University of North Carolina
Texas Tech University Health Sciences Center
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Principal Investigator: Barcey T Levy, PhD, MD University of Iowa
Additional Information:

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Responsible Party: Barcey T. Levy, Professor, University of Iowa Identifier: NCT03264898    
Other Study ID Numbers: R01CA215034 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once the key publications are accepted and finalized, de-identified data and the codebook will be made available to anyone with a legitimate request who follows the Data Sharing agreement.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases