Septin 9 methylated DNA is a sensitive and specific blood test for colorectal cancer

BMC Medicine

Volumn 9, Issue , 2011, Pages

  Warren, Jorja D ^a   Xiong, Wei ^a   Bunker, Ashley M ^b   Vaughn, Cecily P ^b   Furtado, Larissa V ^a   Roberts, William L ^a   Fang, John C ^c   Samowitz, Wade S ^a   Heichman, Karen A ^a  

^a ARUP LABORATORIES   (United States)

^b ARUP INSTITUTE FOR CLINICAL AND EXPERIMENTAL PATHOLOGY   (United States)

^c UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ACTIN; DNA; SEPTIN 9; TUMOR MARKER; UNCLASSIFIED DRUG; SEPT9 PROTEIN, HUMAN; SEPTIN;

ADULT; AGED; ARTICLE; CANCER DIAGNOSIS; CANCER GRADING; CANCER LOCALIZATION; CANCER STAGING; COLONOSCOPY; COLORECTAL ADENOMA; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; DNA DETERMINATION; FALSE POSITIVE RESULT; HUMAN; MAJOR CLINICAL STUDY; PROSPECTIVE STUDY; SENSITIVITY AND SPECIFICITY; SEPTIN 9 METHYLATED DNA TEST; SINGLE BLIND PROCEDURE; BLOOD; CASE CONTROL STUDY; COLORECTAL TUMOR; DNA METHYLATION; EARLY DIAGNOSIS; GENETICS; MASS SCREENING; METHODOLOGY; MIDDLE AGED; REAL TIME POLYMERASE CHAIN REACTION;

ADULT; AGED; CASE-CONTROL STUDIES; COLORECTAL NEOPLASMS; DNA METHYLATION; DNA, NEOPLASM; EARLY DETECTION OF CANCER; HUMANS; MASS SCREENING; MIDDLE AGED; PROSPECTIVE STUDIES; REAL-TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; SEPTINS; TUMOR MARKERS, BIOLOGICAL;

EID: 83355163991     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/1741-7015-9-133     Document Type: Article

References (33)

1. Lansdorp-Vogelaar I, van Ballegooijen M, Zauber A, Habbema DF, Kuipers EJ. Effect of Rising Chemotherapy Costs on the Cost Savings of Colorectal Cancer Screening. J Natl Cancer Inst 2009, 101:1412-1422. 10.1093/jnci/djp319, 2765263, 19779203.
2. Lofton-Day C, Model F, deVos T, Tetzner R, Distler J, Schuster M, Song X, Lesche R, Liebenberg V, Ebert M, Molnar B, Grützmann R, Pilarsky C, Sledziewski A. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem 2008, 54:414-423. 10.1373/clinchem.2007.095992, 18089654.
3. Leon SA, Shapiro B, Sklaroff DM, Yaros MJ. Free DNA in the serum of cancer patients and the effect of therapy. Cancer Res 1977, 37:646-650.
4. Shapiro B, Chakrabarty M, Cohn EM, Leon SA. Determination of circulating DNA levels in patients with benign or malignant gastrointestinal disease. Cancer 1983, 51:2116-2120. 10.1002/1097-0142(19830601)51:11<2116::AID-CNCR2820511127>3.0.CO;2-S, 6188527.
5. Maebo A. Plasma DNA level as a tumor marker in primary lung cancer. Nihon Kyobu Shikkan Gakkai Zasshi 1990, 28:1085-1091.
6. Model F, Osborn N, Ahlquist D, Gruetzmann R, Molnar R, Sipos F, Galamb O, Pilarsky C, Saeger HD, Tulassay Z, Hale K, Mooney S, Lograsso J, Adorjan P, Lesche R, Dessauer A, Kleiber J, Porstmann B, Sledziewski A, Lofton-Day C. Identification and validation of colorectal neoplasia-specific methylation markers for accurate classification of disease. Mol Cancer Res 2007, 5:153-163. 10.1158/1541-7786.MCR-06-0034, 17314273.
7. Grützmann R, Molnar B, Pilarsky C, Habermann JK, Schlag PM, Saeger HD, Miehlke S, Stolz T, Model F, Roblick UJ, Bruch HP, Koch R, Liebenberg V, Devos T, Song X, Day RH, Sledziewski AZ, Lofton-Day C. Sensitive detection of colorectal cancer in peripheral blood by septin 9 DNA methylation assay. PLoS One 2008, 3:e3759. 10.1371/journal.pone.0003759, 2582436, 19018278.
8. deVos T, Tetzner R, Model F, Weiss G, Schuster M, Distler J, Steiger KV, Grützmann R, Pilarsky C, Habermann JK, Fleshner PR, Oubre BM, Day R, Sledziewski AZ, Lofton-Day C. Circulating methylated SEPT9 DNA in plasma is a biomarker for colorectal cancer. Clin Chem 2009, 55:1337-1346. 10.1373/clinchem.2008.115808, 19406918.
9. Tänzer M, Baluff B, Distler J, Hale K, Leodolter A, Röcken T, Molnar B, Schmid R, Lofton-Day C, Schuster T, Ebert MP. Performance of Epigenetic Markers SEPT9 and ALX4 in Plasma for Detection of Colorectal Precancerous Lesions. PLoS One 2010, 5:e9061. 10.1371/journal.pone.0009061, 2816214, 20140221.
10. Church TR, Wandell M, Lofton-Day C, Mongin SJ, Blumenstein BA, Allen JI, Roesch T, Osborn N, Snover D, Day R, Ransohoff DF. Prospective clinical validation of an assay for methylated SEPT9 DNA in human plasma as a colorectal cancer screening tool in average risk men and women 50 years and older. Digestive Disease Week 2010, 1-5. LB-711d.
11. Newcombe RG. Two-Sided Confidence Intervals for the Single Proportion: Comparison of Seven Methods. Stat Med 1998, 17:857-872. 10.1002/(SICI)1097-0258(19980430)17:8<857::AID-SIM777>3.0.CO;2-E, 9595616.
12. Wilson EB. Probable Inference, the Law of Succession, and Statistical Inference. J Am Stat Assoc 1927, 22:209-212.
13. Lieberman DA. Clinical practice: Screening for colorectal cancer. N Engl J Med 2009, 361:1179-1187. 10.1056/NEJMcp0902176, 19759380.
14. Hardcastle JD, Chamberlain JO, Robinson MH, Moss MH, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet 1996, 348:1472-1477. 10.1016/S0140-6736(96)03386-7, 8942775.
15. Kronborg O, Fenger C, Olsen J, Jørgensen OD, Søndergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet 1996, 348:1467-1471. 10.1016/S0140-6736(96)03430-7, 8942774.
16. Lindholm E, Brevinge H, Haglind E. Survival benefit in a randomized clinical trial of faecal occult blood screening for colorectal cancer. Br J Surg 2008, 95:1029-1036. 10.1002/bjs.6136, 18563785.
17. Mandel JS, Church TR, Ederer F, Bond JH. Colorectal cancer mortality: effectiveness of biennial screening for fecal occult blood. J Natl Cancer Inst 1999, 91:434-437. 10.1093/jnci/91.5.434, 10070942.
18. Zheng S, Chen K, Liu X, Ma X, Yu H, Chen K, Yao K, Zhou L, Wang L, Qiu P, Deng Y, Zhang S. Cluster randomization trial of sequence mass screening for colorectal cancer. Dis Colon Rectum 2003, 46:51-58. 10.1007/s10350-004-6496-2, 12544522.
19. Saito H, Soma Y, Koeda J, Wada T, Kawaguchi H, Sobue T, Aisawa T, Yoshida Y. Reduction in risk of mortality from colorectal cancer by fecal occult blood screening with immunochemical hemagglutination test. A case-control study. Int J Cancer 1995, 61:465-469. 10.1002/ijc.2910610406, 7759151.
20. Saito H, Soma Y, Nakajima M, Koeda J, Kawaguchi H, Kakizaki R, Chiba R, Aisawa T, Munakata A. A case-control study evaluating occult blood screening for colorectal cancer with fecal occult blood test and an immunochemical hemagglutination test. Oncol Rep 2000, 7:815-819.
21. Thiis-Evensen E, Hoff GS, Sauer J, Langmark F, Majak BM, Vatn MH. Population-based surveillance by colonoscopy: effect on the incidence of colorectal cancer. Telemark Polyp Study I. Scand J Gastroenterol 1999, 34:414-420. 10.1080/003655299750026443, 10365903.
22. Muller AD, Sonnenberg A. Protection by endoscopy against death from colorectal cancer. A case-control study among veterans. Arch Intern Med 1995, 155:1741-1748. 10.1001/archinte.1995.00430160065007, 7654107.
23. Newcomb PA, Norfleet RG, Storer BE, Surawicz TS, Marcus PM. Screening sigmoidoscopy and colorectal cancer mortality. N Engl J Med 1992, 326:653-657. 10.1056/NEJM199203053261001, 1736103.
24. Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med 1993, 329:1977-1981. 10.1056/NEJM199312303292701, 8247072.
25. Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. The Norwegian Colorectal Cancer Prevention (NORCAP) screening study: baseline findings and implementations for clinical work-up in age groups 50-64 years. Scand J Gastroenterol 2003, 38:635-642. 10.1080/00365520310003002, 12825872.
26. Atkin WS, Cook CF, Cuzick J, Edwards R, Northover JM, Wardle J, . U. K. Flexible Sigmoidoscopy Screening Trial Investigators Single flexible sigmoidoscopy screening to prevent colorectal cancer: baseline findings of a UK multicentre randomised trial. Lancet 2002, 359:1291-1300. U. K. Flexible Sigmoidoscopy Screening Trial Investigators.
27. Segnan N, Senore C, Andreoni B, Aste H, Bonelle L, Crosta C, Ferraris R, Gasperoni S, Penna A, Risio M, Rossini FP, Sciallero S, Zappa M, Atkin WS, . SCORE Working Group--Italy Baseline findings of the Italian multicenter randomized controlled trial of "once-only sigmoidoscopy"--SCORE. J Natl Cancer Inst 2002, 94:1763-1772. 10.1093/jnci/94.23.1763, 12464648, SCORE Working Group--Italy.
28. Weissfeld JL, Schoen RE, Pinsky PF, Bresalier RS, Church T, Yurgalevitch S, Austin JH, Prorok PC, Gohagan JK, . PLCO Project Team Flexible sigmoidoscopy in the PLCO cancer screening trial: results from the baseline screening examination of a randomized trial. J Natl Cancer Inst 2005, 97:989-997. 10.1093/jnci/dji175, 15998952, PLCO Project Team.
29. Colorectal Cancer Facts & Figures, American Cancer Society website. accessed March 18, 2011., http://www.cancer.org
30. Rim SH, Joseph DA, Steele CB, Thompson TD, Seeff LC. Colorectal Cancer Screening--United States 2002, 2004, 2006, and 2008. MMWR Surveill Summ 2011, 60(Suppl):42-46.
31. Meissner HI, Breen N, Klabunde CN, Vernon SW. Patterns of Colorectal Cancer Screening Uptake among Men and Women in the United States. Cancer Epidemiol Biomarkers Prev 2006, 15:389-394. 10.1158/1055-9965.EPI-05-0678, 16492934.
32. Klabunde CN, Lanier D, Nadel MR, McLeod C, Yuan G, Vernon SW. Colorectal cancer screening by primary care physicians: recommendations and practices, 2006-2007. Am J Prev Med 2009, 37:8-16. 10.1016/j.amepre.2009.03.008, 2727732, 19442479.
33. Moawad FJ, Maydonovitch CL, Cullen PA, Barlow DS, Jenson DW, Cash BD. CT Colonography May Improve Colorectal Cancer Screening Compliance. Am J Roentgenol 2010, 195:1118-1123.