Development and clinical validation of a blood test based on 29-gene expression for early detection of colorectal cancer
- Ciarloni, Laura Novigenix SA, Biopôle IV, Epalinges, Switzerland
- Ehrensberger, Sahar Hosseinian Novigenix SA, Biopôle IV, Epalinges, Switzerland
- Imaizumi, Natsuko Novigenix SA, Biopôle IV, Epalinges, Switzerland
- Monnier-Benoit, Sylvain Novigenix SA, Biopôle IV, Epalinges, Switzerland
- Nichita, Cristina Service de Gastro-entérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
- Myung, Seung-Jae Department of Internal Medicine, ASAN Medical Center, Seoul, Korea
- Kim, Joo Sung Seoul National Univerisity, Korea
- Song, Si Young Internal Medicine, Yonsei University College of Medicine, Korea
- Kim, Tae Il Department of Internal Medicine, Yonsei University College of Medicine, Korea
- Weg, Boudewijn van der Gastroenterologie, Spital Thun, Switzerland
- Meier, Rémy Gastroenterology, Hepatology and Nutrition, Kantonsspital Liestal, Switzerland
- Borovicka, Jan Abt.Gastroenterologie/Hepatologie, Kantonsspital St.Gallen, Switzerland
- Beglinger, Christoph Department of Gastroenterology, University Hospital of Basel, Switzerland
- Vallet, Cédric Service de Chirurgie, Ensemble Hospitalier de la Côte, Switzerland
- Maerten, Philippe Internal Medicine, Clinique Cecil, Lausanne, Switzerland
- Rüegg, Curzio Pathology, Department of Medicine, Faculty of Sciences, University of Fribourg, Switzerland
- Dorta, Gian Service de Gastro-entérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
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28.04.2016
Published in:
- Clinical Cancer Research. - 2016, vol. 22, no. 18, p. 4604-4611
English
A blood test for colorectal cancer (CRC) screening is a valuable tool to for testing asymptomatic individuals and reducing CRC-related mortality. The objective of this study was to develop and validate a novel blood test able to differentiate patients with CRC and adenomatous polyps (AP) from individuals with a negative colonoscopy. Experimental Design: A case-control, multicenter clinical study was designed to collect blood samples from patients referred for colonoscopy or surgery. Predictive algorithms were developed on 75 controls, 61 large AP (LAP) {greater than or equal to}1cm, 45 CRC, and independently validated on 74 controls, 42 LAP, 52 CRC (23 Stages I-II) as well as on 245 cases including other colorectal findings and diseases other than CRC. The test is based on a 29-gene panel expressed in peripheral blood mononuclear cells alone or in combination with established plasma tumor markers. Results: The 29-gene algorithm detected CRC and LAP with a sensitivity of 79.5% and 55.4%, respectively, with 90.0% specificity. Combination with the protein tumor markers CEA and CYFRA21-2 resulted in a specificity increase (92.2%) with a sensitivity for CRC and LAP detection of 78.1% and 52.3%, respectively. Conclusions: We report the validation of a novel blood test, Colox®, for the detection of CRC and LAP based on a 29-gene panel and the CEA and CYFRA21-1 plasma biomarkers. The performance and convenience of this routine blood test provides physicians a useful tool to test average risk individuals unwilling to undergo upfront colonoscopy.
- Faculty
- Faculté des sciences et de médecine
- Department
- Médecine 3ème année
- Language
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- English
- Classification
- Biological sciences
- License
- License undefined
- Identifiers
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- RERO DOC 260741
- DOI 10.1158/1078-0432.CCR-15-2057
- Persistent URL
- https://folia.unifr.ch/unifr/documents/304891
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