Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study
| Autor: | Robert L. Barclay, Thomas König, David A. Johnson, Jürgen Beck, Gunter Weiss, Klaus Mergener, Nicholas T. Potter |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Male
Health Screening Colorectal cancer Colonoscopy lcsh:Medicine Gastroenterology Biochemistry DNA amplification Nucleic Acids Adenocarcinomas Cancer screening Blood plasma Molecular Cell Biology Medicine and Health Sciences Mass Screening Public and Occupational Health Prospective Studies Prospective cohort study lcsh:Science Early Detection of Cancer Aged 80 and over education.field_of_study Multidisciplinary medicine.diagnostic_test Colon Adenocarcinoma Middle Aged Oncology Occult Blood Epigenetics Female DNA modification Colorectal Neoplasms Cancer Screening Research Article medicine.medical_specialty Population Colonic Polyps Carcinomas Sensitivity and Specificity Rectal Cancer Internal medicine Gastrointestinal Tumors medicine Genetics Cancer Detection and Diagnosis Blood test Humans education Mass screening Aged Neoplasm Staging Gynecology Biology and life sciences business.industry lcsh:R Cancers and Neoplasms Reproducibility of Results DNA Cell Biology medicine.disease lcsh:Q business Septins |
| Zdroj: | PLoS ONE, Vol 9, Iss 6, p e98238 (2014) PLoS ONE |
| ISSN: | 1932-6203 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|