Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer

Gut

Volumn 63, Issue 2, 2014, Pages 317-325

  Church, Timothy Robert ^a   Wandell, Michael ^b   Lofton Day, Catherine ^c   Mongin, Steven J ^a   Burger, Matthias ^c   Payne, Shannon R ^d   Castaños Vélez, Esmeralda ^e   Blumenstein, Brent A ^f   Rösch, Thomas ^g   Osborn, Neal ^h   Snover, Dale ⁱ   Day, Robert W ^c   Ransohoff, David F ^j  

^a UNIVERSITY OF MINNESOTA   (United States)

^b RICE UNIVERSITY   (United States)

^c EPIGENOMICS AG   (Germany)

^d Santaurus Inc   (United States)

^e CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^f Trial Architecture Consulting   (United States)

^g UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^h Atlanta Gastroenterology Associates   (United States)

ⁱ UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^j UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DNA; TUMOR MARKER;

ADULT; ADVANCED CANCER; ARTICLE; ASYMPTOMATIC DISEASE; CANCER DIAGNOSIS; CANCER STAGING; COLONOSCOPY; COLORECTAL ADENOMA; COLORECTAL CANCER; COLORECTAL CARCINOMA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DNA DETERMINATION; DNA METHYLATION; FEMALE; GENE; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PRIORITY JOURNAL; PROSPECTIVE STUDY; REAL TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; SEPT9 GENE;

EID: 84891743167     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2012-304149     Document Type: Article

References (44)

1. Jemal A, Siegel R, Xu J, et al. Cancer statistics, 2010. CA Cancer J Clin 2010;60:277-300.
2. Ferlay J, Autier P, Boniol M, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007;18:581-92. (Pubitemid 46359643)
3. Baylin SB, Esteller M, Rountree MR, et al. Aberrant patterns of DNA methylation, chromatin formation and gene expression in cancer. Hum Mol Genet 2001;10:687-92. (Pubitemid 32331576)
4. Ebert MP, Mooney SH, Tonnes-Priddy L, et al. Hypermethylation of the TPEF/HPP1 gene in primary and metastatic colorectal cancers. Neoplasia 2005;7:771-8.
5. Momparler RL. Cancer epigenetics. Oncogene 2003;22:6479-83. (Pubitemid 37372327)
6. Esteller M. Relevance of DNA methylation in the management of cancer. Lancet Oncol 2003;4:351-8. (Pubitemid 36748422)
7. Zou HZ, Yu BM, Wang ZW, et al. Detection of aberrant p16 methylation in the serum of colorectal cancer patients. Clin Cancer Res 2002;8:188-91.
8. Lofton-Day C, Model F, Devos T, et al. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem 2008;54:414-23. (Pubitemid 351302625)
9. Grutzmann R, Molnar B, Pilarsky C, et al. Sensitive detection of colorectal cancer in peripheral blood by septin 9 DNA methylation assay. PLoS One 2008;3:e3759.
10. De Vos T, Tetzner R, Model F, et al. Circulating methylated SEPT9 DNA in plasma is a biomarker for colorectal cancer. Clin Chem 2009;55:1337-46.
11. PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening. http://clinicaltrials.gov/ct2/show/NCT00855348 (accessed 3 Feb. 2013).
12. Levin B, Lieberman DA, McFarland B, et al. 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. Gastroenterol 2008;134:1570-95. (Pubitemid 351615355)
13. Rösch T, Weiss G. Potential of a new blood test for colorectal cancer screening - the septin 9 gene biomarker. Eur Oncol 2009;6:51-4.
14. American Joint Committee on Cancer. AJCC cancer staging manual, 7th edn. New York, NY: Springer, 2010.
15. US Census Bureau. Monthly Population Estimates, 2000 to 2003 (for 1 July 2000). 2003. http://www.census.gov/popest/data/historical/2000s/vintage-2003/ index.html (accessed 3 Feb. 2013).
16. US Census Bureau. International Data Base (IDB), 2009. http://www.census.gov/population/international/data/idb/informationGateway.php (accessed 3 Feb. 2013).
17. Rothman KJ, Greenland S, eds. Modern epidemiology, 2nd Edn. Philadelphia, PA: Lippincott-Raven, 1998.
18. Szklo M, Nieto FJ. Epidemiology: beyond the basics. Gaithersburg, Maryland: Aspen, 2000.
19. Horvitz D, Thompson D. A generalization of sampling without replacement from a finite universe. J Am Stat Assoc 1952;47:663-85.
20. Efron B, Tibshirani RJ. An introduction to the bootstrap. New York: Chapman and Hall, 1993.
21. Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934;26:404-13.
22. R Development Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, 2010.
23. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. BMJ 2003;326:41-4. (Pubitemid 36110721)
24. Warren J, Xiong W, Bunker A, et al. Septin 9 methylated DNA is a sensitive and specific blood test for colorectal cancer. BMC Medicine 2011;9:133.
25. Tao S, Hundt S, Haug U, et al. Sensitivity estimates of blood-based tests for colorectal cancer detection: impact of overrepresentation of advanced stage disease. Am J Gastroenterol 2011;106:242-53.
26. Mandel JS, Bond JH, Church TR, et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. N Engl J Med 1993;328:1365-71 (Pubitemid 23131388)
27. [erratum N Engl J Med 1993;329:672].
28. Kronborg O, Fenger C, Olsen J, et al. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet 1996;348:1467-71. (Pubitemid 26400241)
29. Hardcastle JD, Chamberlain JO, Robinson MH, et al. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet 1996;348:1472-7. (Pubitemid 26400242)
30. Mandel JS, Church TR, Ederer F, et al. Colorectal cancer mortality: effectiveness of biennial screening for fecal occult blood. J Natl Cancer Inst 1999;91:434-7. (Pubitemid 29128279)
31. Mandel JS, Church TR, Bond JH, et al. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med 2000;343:1603-7. (Pubitemid 32162983)
32. Atkin WS, Edwards R, Kralj-Hans I, et al. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. Lancet 2010;375:1624-33.
33. Shapiro JA, Seeff LC, Thompson TD, et al. Colorectal cancer test use from the 2005 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev 2008;17:1623-30.
34. Wuppermann D, Wuppermann U, Riemann J. Actual state of knowledge of the german population about the early detection of colorectal cancer-a study by the "Stiftung Lebens Blicke" in cooperation with the institute for demoscopy in Allensbach. Z Gastroenterol 2009;47:1132-6.
35. Benson VS, Patnick J, Davies AK, et al. Colorectal cancer screening: a comparison of 35 initiatives in 17 countries. Int J Cancer 2008;122:1357-67. (Pubitemid 351287237)
36. Whitlock EP, Lin JS, Liles E, et al. Screening for colorectal cancer: a targeted, updated systematic review for the U. S. Preventive Services Task Force. Ann Intern Med 2008;149:638-58.
37. Zhu MM, Xu XT, Nie F, et al. Comparison of immunochemical and guaiac-based fecal occult blood test in screening and surveillance for advanced colorectal neoplasms: a meta-analysis. J Dig Dis 2010;11:148-60.
38. Vart G, Banzi R, Minozzi S. Comparing participation rates between immunochemical and guaiac faecal occult blood tests: a systematic review and meta-analysis. Prev Med 2012;55:87-92.
39. National Institute for Pubic Health and the Environment. Bowel cancer screening programme: ministry of Health. The Netherlands: Welfare and Sport, 2011.
40. Ahlquist DA, Zou H, Domanico M, et al. Next-generation stool DNA test accurately detects colorectal cancer and large adenomas. Gastroenterology 2012;142:248-56.
41. Ahlquist DA, Taylor WR, Mahoney DW, et al. The stool DNA test is more accurate than the plasma septin 9 test in detecting colorectal neoplasia. Clin Gastroenterol Hepatol 2012;10:272-7.e1.
42. Pignone M, Russell L, Wagner J, eds. Economic models of colorectal cancer screening in average-risk adults: workshop summary. Washington, DC: National Academies Press, 2005.
43. Zauber AG, Lansdorp-Vogelaar I, Knudsen AB, et al. Evaluating test strategies for colorectal cancer screening: a decision analysis for the U. S. Preventive Services Task Force. Ann Intern Med 2008;149:659-69.
44. Ahlquist DA, Shuber AP. Stool screening for colorectal cancer: evolution from occult blood to molecular markers. Clin Chim Acta 2002;315:157-68. (Pubitemid 33145255)