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| Item Type: | Article |
|---|---|
| Title: | Sensitive detection of colorectal cancer in peripheral blood by septin 9 DNA methylation assay |
| Creators Name: | Gruetzmann, R., Molnar, B., Pilarsky, C., Habermann, J.K., Schlag, P.M., Saeger, H.D., Miehlke, S., Stolz, T., Model, F., Roblick, U.J., Bruch, H.P., Koch, R., Liebenberg, V., Devos, T., Song, X., Day, R.H., Sledziewski, A.Z. and Lofton-Day, C. |
| Abstract: | BACKGROUND: Colorectal cancer (CRC) is the second leading cause of cancer deaths despite the fact that detection of this cancer in early stages results in over 90% survival rate. Currently less than 45% of at-risk individuals in the US are screened regularly, exposing a need for better screening tests. We performed two case-control studies to validate a blood-based test that identifies methylated DNA in plasma from all stages of CRC. METHODOLOGY/PRINCIPAL FINDINGS: Using a PCR assay for analysis of Septin 9 (SEPT9) hypermethylation in DNA extracted from plasma, clinical performance was optimized on 354 samples (252 CRC, 102 controls) and validated in a blinded, independent study of 309 samples (126 CRC, 183 controls). 168 polyps and 411 additional disease controls were also evaluated. Based on the training study SEPT9-based classification detected 120/252 CRCs (48%) and 7/102 controls (7%). In the test study 73/126 CRCs (58%) and 18/183 control samples (10%) were positive for SEPT9 validating the training set results. Inclusion of an additional measurement replicate increased the sensitivity of the assay in the testing set to 72% (90/125 CRCs detected) while maintaining 90% specificity (19/183 for controls). Positive rates for plasmas from the other cancers (11/96) and non-cancerous conditions (41/315) were low. The rate of polyp detection (>1 cm) was approximately 20%. CONCLUSIONS/SIGNIFICANCE: Analysis of SEPT9 DNA methylation in plasma represents a straightforward, minimally invasive method to detect all stages of CRC with potential to satisfy unmet needs for increased compliance in the screening population. Further clinical testing is warranted. |
| Keywords: | Algorithms, Case-Control Studies, Colorectal Neoplasms, DNA Methylation, GTP Phosphohydrolases, Mass Screening, Polymerase Chain Reaction, Sensitivity and Specificity, Treatment Outcome |
| Source: | PLoS ONE |
| ISSN: | 1932-6203 |
| Publisher: | Public Library of Science |
| Volume: | 3 |
| Number: | 11 |
| Page Range: | e3759 |
| Date: | 19 November 2008 |
| Official Publication: | https://doi.org/10.1371/journal.pone.0003759 |
| PubMed: | View item in PubMed |
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