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PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.

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

Author information

1
Gastroenterology Division, Eastern VA Medical School, Norfolk, Virginia, United States of America.
2
Rockford Gastroenterology Associates, Ltd., Rockford, Illinois, United States of America.
3
Digestive Health Specialists, Tacoma, Washington, United States of America.
4
Epigenomics AG, Berlin Germany.
5
Molecular Pathology Laboratory Network, Inc., Maryville, Tennessee, United States of America.

Abstract

BACKGROUND:

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.

OBJECTIVE:

To compare the performance of a new Septin9 DNA methylation based blood test with a fecal immunochemical test (FIT) for CRC screening.

DESIGN:

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.

MEASUREMENTS:

Plasma and fecal samples were analyzed using the Epi proColon and OC Fit-Check tests respectively.

RESULTS:

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%.

CONCLUSIONS:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01580540.

PMID:
24901436
PMCID:
PMC4046970
DOI:
10.1371/journal.pone.0098238
[Indexed for MEDLINE]
Free PMC Article

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