A first evaluation of the Septin 9 test in the Czech Republic
Authors:
P. Sychra 1; V. Procházka 1
; L. Roubalová 2
; J. Zapletalová 3; M. Konečný 1
Authors place of work:
II. interní klinika – gatroenterologická a hepatologická LF UP a FN Olomouc
1; Oddělení klinické biochemie, FN Olomouc
2; Ústav lékařské biofyziky, LF UP Olomouc
3
Published in the journal:
Gastroent Hepatol 2016; 70(4): 300-304
Category:
Klinická a experimentální gastroenterologie: původní práce
doi:
https://doi.org/10.14735/amgh2016300
Summary
Colorectal cancer still persists despite advances in diagnosis and therapy. The unfulfilled expectations of screening programs has led to the development of new tests based on molecular biology for early diagnosis. Reports over the past 15 years concerning the possibility of using epigenetic markers of colon cancer for colon cancer diagnosis led us to study the feasibility of using the Septin 9 test comprised in the Epi proColon Plasma Quick Kit on a group of 108 patients undergoing colonoscopy, the reference method. We were interested in the sensitivity and specificity of the test under our clinical conditions. Among the 108 patients, colonoscopy detected adenomas in 41, carcinomas in 21, and no findings in 46 persons. In the patients with negative colonoscopic findings, the Septin 9 test was negative for 34 and positive for two, with 10 people were classified as “not detected” (ND) because the DNA concentration in the isobath was below the required level. In patients with a confirmed adenoma, the Septin 9 test was negative in 26 and positive in one, and 14 people were classified as ND. In patients with cancer, the Septin 9 test was negative in seven and positive in seven, and seven were classified as ND. The sensitivity of the Septin 9 assay was 19.5% and the specificity was 94.4%. Septin 9 test positivity was found significantly more often in people with cancer than in those with an adenoma or with negative findings on colonoscopy (p = 0.003). The Septin 9 test showed a high degree of specificity (94.4%). It was disappointing that the test showed very low sensitivity in patients with adenoma (only 3.7%). The overall results of the study were affected by the high proportion of tests in which the concentration of DNA in the isolate was insufficient, necessitating that these patients be classified as ND.
Key words:
septins – Septin 9 – sensitivity – specificity – colorectal neoplasms
The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.
The Editorial Board declares that the manuscript met the ICMJE „uniform requirements“ for biomedical papers.
Submitted:
7. 7. 2016
Accepted:
8. 8. 2016
Zdroje
1. Kocna P, Vanickova Z, Zima T. Laboratory screening markers in gastroenerology – state of the art. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub 2013; 157(2): 91– 97. doi: 10.5507/ bp.2013.027.
2. Fric P, Zavoral M, Dvorakova H et al. An adapted program of colorectal cancer screening – 7 years experience and cost-benefit analysis. Hepato-gastroenterology 1994; 41(5): 413– 416.
3. Zavoral M, Suchanek S, Majek O et al. Colorectal cancer screening: 20 years of development and recent progress. World J Gastroenterol 2014; 20(14): 3825– 3834. doi: 10.3748/ wjg.v20.i14.3825.
4. Suchanek S, Majek O, Vojtechova G et al. Colorectal cancer prevention in the Czech Republic: time trends in performance indicators and current situation after 10 years of screening. Eur J Cancer Prev 2014; 23(1): 18– 26. doi: 10.1097/ CEJ.0b013e328364f203.
5. Wohl P, Bednařík M, Wohl P et al. Comparison of various strategies for colorectal cancer screening tests. Eur J Gastroenterol Hepatol 2011; 23(12): 1157– 1164. doi: 10.1097/ MEG.0b013e3283491438.
6. Fukushige S, Horii A. DNA methylation in cancer: a gene silencing mechanism and the clinical potential of its biomarkers. Tohoku J Exp Med 2013; 229(3): 173– 185.
7. Grützmann 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(11): e3759. doi: 10.1371/ journal.pone.0003759.
8. Warren JD, Xiong W, Bunker AM. Septin 9 methylated DNA is a sensitive and specific blood test for colorectal cancer. BMC Med 2011; 9: 133. doi: 10.1186/ 1741-7015-9-133.
9. 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(3): 272– 277. doi: 10.1016/ j.cgh.2011.10.008.
10. Tóth K, Sipos F, Kalmár A et al. Detection of methylated SEPT9 in plasma is a reliable screening method for both left- and right-sided colon cancers. PLoS One 2012; 7(9): e46000. doi: 10.1371/ journal.pone.0046000.
11. Ladabaum U, Allen J, Wandell M et al. Colorectal cancer screening with blood-based biomarkers: cost-effectiveness of methylated Septin 9 DNA versus current strategies. Cancer Epidemiol Biomarkers Prev 2013; 22(9): 1567– 1576. doi: 10.1158/ 1055-9965.EPI-13-0204.
12. Ladabaum U, Alvarez-Osorio L, Rosch T et al. Cost-effectiveness of colorectal cancer screening in Germany: current endoscopic and fecal testing strategies versus plasma methylated Septin 9 DNA. Endosc Int Open 2013; 2(2): E96– E104. doi: 10.1055/ s-0034-1377182.
13. Johnson DA, Barclay RL, Mergener K et al. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLos One 2014; 9(6): e98238. doi: 10.1371/ journal.pone.0098238.
14. Church TR, Wandell M, Lofton-Day C et al. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut 2014; 63(2): 317– 325. doi: 10.1136/ gutjnl-2012-304149.
15. Molnár B, Tóth K, Barták BK et al. Plasma methylated septin 9: a colorectal cancer screening marker. Expert Rev Mol Diagn 2015; 15(2): 171– 184. doi: 10.1586/ 14737159.2015.975212.
16. Jin P, Kang Q, Wang X et al. Performance of a second-generation methylated SEPT9 test in detecting colorectal neoplasm. J Gastroenterol Hepatol 2015; 30(5): 830– 833. doi: 10.1111/ jgh.12855.
17. Li B, Gan A, Chen X et al. Performance of DNA hypermethylation markers in peripheral blood for the detection of colorectal cancer: a meta-analysis and systematic review. PLoS One 2016; 11(5): e0155095. doi: 10.1371/ journal.pone.0155095.
Štítky
Detská gastroenterológia Gastroenterológia a hepatológia Chirurgia všeobecnáČlánok vyšiel v časopise
Gastroenterologie a hepatologie
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