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      Plasma Septin9 versus Fecal Immunochemical Testing for Colorectal Cancer Screening: A Prospective Multicenter Study

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          Abstract

          Background

          Screening improves outcomes related to colorectal cancer (CRC); however, suboptimal participation for available screening tests limits the full benefits of screening. Non-invasive screening using a blood based assay may potentially help reach the unscreened population.

          Objective

          To compare the performance of a new Septin9 DNA methylation based blood test with a fecal immunochemical test (FIT) for CRC screening.

          Design: In this trial, fecal and blood samples were obtained from enrolled patients. To compare test sensitivity for CRC, patients with screening identified colorectal cancer (n = 102) were enrolled and provided samples prior to surgery. To compare test specificity patients were enrolled prospectively (n = 199) and provided samples prior to bowel preparation for screening colonoscopy.

          Measurements

          Plasma and fecal samples were analyzed using the Epi proColon and OC Fit-Check tests respectively.

          Results

          For all samples, sensitivity for CRC detection was 73.3% (95% CI 63.9–80.9%) and 68.0% (95% CI 58.2–76.5%) for Septin9 and FIT, respectively. Specificity of the Epi proColon test was 81.5% (95% CI 75.5–86.3%) compared with 97.4% (95% CI 94.1–98.9%) for FIT. For paired samples, the sensitivity of the Epi proColon test (72.2% –95% CI 62.5–80.1%) was shown to be statistically non-inferior to FIT (68.0%–95% CI 58.2–76.5%). When test results for Epi proColon and FIT were combined, CRC detection was 88.7% at a specificity of 78.8%.

          Conclusions

          At a sensitivity of 72%, the Epi proColon test is non- inferior to FIT for CRC detection, although at a lower specificity. With negative predictive values of 99.8%, both methods are identical in confirming the absence of CRC.

          Trial Registration

          ClinicalTrials.gov NCT01580540

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          Most cited references 20

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          Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study.

          Although tests for occult blood in the feces are widely used to screen for colorectal cancers, there is no conclusive evidence that they reduce mortality from this cause. We evaluated a fecal occult-blood test in a randomized trial and documented its effectiveness. We randomly assigned 46,551 participants 50 to 80 years of age to screening for colorectal cancer once a year, to screening every two years, or to a control group. Participants who were screened submitted six guaiac-impregnated paper slides with two smears from each of three consecutive stools. About 83 percent of the slides were rehydrated. Participants who tested positive underwent a diagnostic evaluation that included colonoscopy. Vital status was ascertained for all study participants during 13 years of follow-up. A committee determined causes of death. A single pathologist determined the stage of each tissue specimen. Differences in mortality from colorectal cancer, the primary study end point, were monitored with the sequential log-rank statistic. The 13-year cumulative mortality per 1000 from colorectal cancer was 5.88 in the annually screened group (95 percent confidence interval, 4.61 to 7.15), 8.33 in the biennially screened group (95 percent confidence interval, 6.82 to 9.84), and 8.83 in the control group (95 percent confidence interval, 7.26 to 10.40). The rate in the annually screened group, but not in the biennially screened group, was significantly lower than that in the control group. Reduced mortality in the annually screened group was accompanied by improved survival in those with colorectal cancer and a shift to detection at an earlier stage of cancer. Annual fecal occult-blood testing with rehydration of the samples decreased the 13-year cumulative mortality from colorectal cancer by 33 percent.
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            Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology.

            In the United States, colorectal cancer (CRC) is the third most common cancer diagnosed among men and women and the second leading cause of death from cancer. CRC largely can be prevented by the detection and removal of adenomatous polyps, and survival is significantly better when CRC is diagnosed while still localized. In 2006 to 2007, the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology came together to develop consensus guidelines for the detection of adenomatous polyps and CRC in asymptomatic average-risk adults. In this update of each organization's guidelines, screening tests are grouped into those that primarily detect cancer early and those that can detect cancer early and also can detect adenomatous polyps, thus providing a greater potential for prevention through polypectomy. When possible, clinicians should make patients aware of the full range of screening options, but at a minimum they should be prepared to offer patients a choice between a screening test that primarily is effective at early cancer detection and a screening test that is effective at both early cancer detection and cancer prevention through the detection and removal of polyps. It is the strong opinion of these 3 organizations that colon cancer prevention should be the primary goal of screening.
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              American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected].

              This document is the first update of the American College of Gastroenterology (ACG) colorectal cancer (CRC) screening recommendations since 2000. The CRC screening tests are now grouped into cancer prevention tests and cancer detection tests. Colonoscopy every 10 years, beginning at age 50, remains the preferred CRC screening strategy. It is recognized that colonoscopy is not available in every clinical setting because of economic limitations. It is also realized that not all eligible persons are willing to undergo colonoscopy for screening purposes. In these cases, patients should be offered an alternative CRC prevention test (flexible sigmoidoscopy every 5-10 years, or a computed tomography (CT) colonography every 5 years) or a cancer detection test (fecal immunochemical test for blood, FIT).
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2014
                5 June 2014
                : 9
                : 6
                Affiliations
                [1 ]Gastroenterology Division, Eastern VA Medical School, Norfolk, Virginia, United States of America
                [2 ]Rockford Gastroenterology Associates, Ltd., Rockford, Illinois, United States of America
                [3 ]Digestive Health Specialists, Tacoma, Washington, United States of America
                [4 ]Epigenomics AG, Berlin Germany
                [5 ]Molecular Pathology Laboratory Network, Inc., Maryville, Tennessee, United States of America
                Sapporo Medical University, Japan
                Author notes

                Competing Interests: The authors have read the journal’s policy and have the following conflicts: David A. Johnson MD: •Consultant/clinical investigator- Epigenomics. •Advisory Board Given Imaging, CRH Medical, Abbivie, Jansen/Centacor, Takeda, AstraZeneca, Phizer, Medivo •Clinical investigator – EXACT Sciences. Klaus Mergener, MD, PhD, MBA: •Clinical investigator - Epigenomics •Clinical investigator - GI View Ltd •Clinical investigator - CapsoVision •Consultant/clinical investigator - Intromedic •Consultant, Olympus America •Advisory Board - Colon Prep Center •Advisory Board – angelMD. Robert Barclay, MD: •Clinical investigator - Epigenomics. Gunter Weiss: •Epigenomics employee. Thomas König: •Epigenomics employee. Jürgen Beck: •Epigenomics employee at the time of the study. Nicholas Potter, PhD: •Medical Advisory Board – Epigenomics •Clinical investigator- Epigenomics. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

                Conceived and designed the experiments: GW TK JB. Performed the experiments: DAJ RLB KM NTP. Analyzed the data: GW TK. Contributed reagents/materials/analysis tools: DAJ RLB KM GW TK JB NTP. Wrote the paper: DAJ RLB KM GW TK JB NTP.

                Article
                PONE-D-14-01212
                10.1371/journal.pone.0098238
                4046970
                24901436

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Pages: 8
                Funding
                The study was sponsored by Epigenomics AG (Berlin, Germany) http://www.epigenomics.com. Epigenomics provided support in the form of salaries for authors GW, TK, JB, and designed this study which was conducted at US clinical sites through an independent clinical research organization (CRO). Results were collated and analyzed consecutively by the sponsor following completion of testing. As per study protocol, manuscript preparation and the decision to publish were overseen by a publication steering committee comprising of DAJ, JB, KM, NTP and RLB. Laboratory testing was performed at an independent US clinical laboratory on all submitted specimens. Eastern VA Medical School, Rockford Gastroenterology Associates, Ltd., Digestive Health Specialists and Molecular Pathology Laboratory Network, Inc., provided support in the form of salaries for authors DAJ, RLB, KM, NTP, respectively, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.
                Categories
                Research Article
                Biology and life sciences
                Biochemistry
                DNA
                DNA amplification
                DNA modification
                Nucleic Acids
                Cell Biology
                Molecular Cell Biology
                Genetics
                Epigenetics
                Medicine and Health Sciences
                Oncology
                Cancer Detection and Diagnosis
                Cancer Screening
                Cancers and Neoplasms
                Carcinomas
                Adenocarcinomas
                Colon Adenocarcinoma
                Gastrointestinal Tumors
                Colonic Polyps
                Rectal Cancer
                Public and Occupational Health
                Health Screening

                Uncategorized

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