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Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion

ABSTRACT: Objectives: Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of Americans are up to date with screening, partly because many individuals find these two tests inconvenient or unacceptable for a variety of reasons. There is an unmet need for a non-invasive test that does not require bowel preparation or handling stool, and the Septin9 DNA blood test may be an alternative for those individuals who would otherwise remain unscreened. Aims: Aim 1: To measure screening uptake with a blood test in screen-resistant patients who have declined both colonoscopy and fecal immunochemical testing (FIT) at the Manhattan VA Medical Center * Sub-Aim 1a: To assess the proportion of those with a positive blood-based screening test who undergo diagnostic colonoscopy * Sub-Aim 1b: To describe the endoscopic findings on diagnostic colonoscopy Aim 2: To survey screen-resistant patients to understand their beliefs and attitudes about colorectal cancer screening and testing options We hypothesize that a substantial proportion of patients who have refused colonoscopy and FIT will accept the blood test. We hypothesize this will be driven by the convenience of the blood test. Methods: This will be randomized controlled trial of individuals who have refused colonoscopy and FIT within past 6 months. Eligible patients will be randomized 1:1 to the intervention or control group. Both groups will be invited to participate in navigated colonoscopy or FIT by letter and telephone call. The intervention group will also be invited to participate in the blood test if they refuse colonoscopy and FIT. We will enroll 180 participants in each group (total n=360).

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2278536 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually screened for CRC. The leading methods, colonoscopy and FIT (fecal immunochemical test) testing, both have patient-associated barriers that reduce their use. The combination of bowel preparation and procedure time are barriers to colonoscopy, while stool handling as part of the sampling protocol reduces FIT usage. It has been hypothesized and supported by a variety of preference studies that the availability of a blood-based assay for CRC screening would increase patient participation and adherence to CRC screening by reducing barriers that prevent participation. This study is designed to investigate the relative participation in CRC screening in average risk, screening eligible patients with demonstrated non-adherence to guideline-recommended screening modalities. Participation with the fecal immunochemical test (FIT) and the blood-based Epi proColon test will be examined. Screening eligible average-risk patients identified as non-adherent by medical record will be eligible for the study. Potential subjects will be recruited to participate in a study via mailing and/or at a clinic visit. All study subjects will be enrolled at a clinic visit and will be randomized in two study arms. Those assigned to Arm 1 will be offered a FIT test kit for home use. Those assigned to Arm 2 will be offered a blood draw for the Epi proColon test. Rates of adherence will be compared between those that accept and complete the blood test and those that accept and complete the FIT test. A passive control, usual care arm will comprise subjects meeting eligibility criteria, but not recruited for or participating in the study. In conjunction with published data (Johnson et al, 2014), the relative utilization of the blood test will be compared to the screening participation via FIT. Increased participation with the Epi proColon blood test could increase screening rates in the non-adherent population. Additionally, for those testing positive in the trial, the rate of adherence to colonoscopy will be determined.

Project description:Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and affects men and women almost equally. The United States Preventative Services Task Force (USPSTF) currently recommends screening with any of three options, which include fecal testing, flexible sigmoidoscopy, or colonoscopy. Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually or biennially has been shown to decrease mortality 15-33% primarily through detection of early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance of benefit and risk in screening populations, is the least expensive, and is the preferred method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers significant improvements over the gFOBT, most notably that it is easier to use (requires fewer samples and no dietary or medication restrictions) and is more sensitive than the gFOBT with respect to detecting both CRC and precancerous adenomas. As a result of improved test performance and usability, in 2008 multiple professional societies endorsed the use of four types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the OC-Micro FIT as the fecal screening test in all regions. In recent years, intensive efforts have been undertaken to identify blood-based markers that may provide a promising alternative or supplement to fecal testing for non-invasive CRC screening. One method under development is to identify aberrantly methylated genes in cancer tissue through a blood test. Prior studies have explored those specific colorectal cancer genes that show the highest differences in methylation between the cancer and background genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is relatively well studied. The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded colonoscopies. The population of interest for this study-those with a positive screening OC-Micro fecal immunochemical test-has a CRC prevalence of approximately 5%. Knowing how well Septin 9 can identify those without cancer prior to colonoscopy is important largely because colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can cause serious complications.

Project description:Early detection by screening significantly reduces mortality from colorectal cancer (CRC). However, CRC screening rates have plateaued, with a considerable segment of the population remaining unscreened. Not being up to date with screening was associated with an approximate 3-fold risk for CRC-related mortality. There are different well-established CRC screening modalities, including invasive and non-invasive, which detect both polyps and cancer or cancer alone. Colonoscopy remains the dominant screening modality in the U.S.; however, colonoscopy uptake is low due to the invasiveness, perception of discomfort and embarrassment, logistical challenges, cost, and potential risks. Increasing patient compliance and adherence to screening is critical to improving CRC outcomes. A key to enhancing screening participation is patient acceptance of the testing method. A blood-based screening test presents an opportunity to overcome some challenging barriers. Blood-based tests are non-invasive compared to colonoscopy and can easily be part of a standard medical office appointment for a wellness check or scheduled visits to manage chronic illnesses and be completed at the point of care. This study will examine patient preference to use a blood-based screening test and compliance with CRC screening recommendations after failing to complete the FIT (Fecal Immunochemical Test)/FOBT (Fecal Occult Blood Test) or colonoscopy order in six months. Compliance with CRC screening is particularly poor among medically underserved populations, and most of these vulnerable individuals use federally qualified health centers (FQHCs) to obtain care. Implementing a blood-based screening test at FQHCs has the potential to improve CRC screening uptake and adherence and improve health disparities in medically underserved populations. This study seeks to answer the following four questions: 1) What is the acceptability of a blood-based screening as an alternative for patients who failed to complete a prior order using traditional screening methods? 2) Are patients who failed to comply with traditional screening methods more likely to comply with a blood-based screening test? 3) What is the effect of offering a blood-based screening test for patients who are non-compliance with traditional screening methods on overall CRC screening rates? 4) What are the facilitators and barriers to implementing the blood-based screening test in clinical settings?

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Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion

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