Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study

• Published in: PloS one 2014-06, Vol.9 (6), p.e98238-e98238
• Main Authors: Johnson, David A, Barclay, Robert L, Mergener, Klaus, Weiss, Gunter, König, Thomas, Beck, Jürgen, Potter, Nicholas T
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Analysis; Biology and life sciences; Blood; Blood tests; Cancer; Cancer research; Cancer screening; Cell division; Colon; Colonoscopy; Colorectal cancer; Colorectal carcinoma; Colorectal Neoplasms - diagnosis; Colorectal Neoplasms - pathology; Deoxyribonucleic acid; DNA; DNA methylation; Early Detection of Cancer - methods; Early Detection of Cancer - standards; Enrollments; Feces; Female; Gastroenterology; Gene expression; Humans; Intestine; Male; Mass Screening - methods; Mass Screening - standards; Medical prognosis; Medical screening; Medicine and Health Sciences; Methylation; Middle Aged; Mortality; Neoplasm Staging; Occult Blood; Patients; Prospective Studies; Reproducibility of Results; Sensitivity; Sensitivity and Specificity; Septins - genetics; Statistical analysis; Statistical methods; Surgery; Systematic review; Task forces
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0098238

Screening improves outcomes related to colorectal cancer (CRC); however, suboptimal participation for available screening tests limits the full benefits of screening. Non-invasive screening using a blood based assay may potentially help reach the unscreened population. To compare the performance of a new Septin9 DNA methylation based blood test with a fecal immunochemical test (FIT) for CRC screening. In this trial, fecal and blood samples were obtained from enrolled patients. To compare test sensitivity for CRC, patients with screening identified colorectal cancer (n = 102) were enrolled and provided samples prior to surgery. To compare test specificity patients were enrolled prospectively (n = 199) and provided samples prior to bowel preparation for screening colonoscopy. Plasma and fecal samples were analyzed using the Epi proColon and OC Fit-Check tests respectively. For all samples, sensitivity for CRC detection was 73.3% (95% CI 63.9-80.9%) and 68.0% (95% CI 58.2-76.5%) for Septin9 and FIT, respectively. Specificity of the Epi proColon test was 81.5% (95% CI 75.5-86.3%) compared with 97.4% (95% CI 94.1-98.9%) for FIT. For paired samples, the sensitivity of the Epi proColon test (72.2% -95% CI 62.5-80.1%) was shown to be statistically non-inferior to FIT (68.0%-95% CI 58.2-76.5%). When test results for Epi proColon and FIT were combined, CRC detection was 88.7% at a specificity of 78.8%. At a sensitivity of 72%, the Epi proColon test is non- inferior to FIT for CRC detection, although at a lower specificity. With negative predictive values of 99.8%, both methods are identical in confirming the absence of CRC. ClinicalTrials.gov NCT01580540.