Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer
By T. Church, M. Wandell, C. Lofton-Day, S. Mongin, M. Burger, S. Payne, E. Castaños‐Vélez, B. Blumenstein, T. Rösch, Neal Osborn and 3 more. Gut, 2013
755 citations recorded by the source corpus.
Background As screening methods for colorectal cancer (CRC) are limited by uptake and adherence, further options are sought. A blood test might increase both, but none has yet been tested in a screening setting. Objective We prospectively assessed the accuracy of circulating methylated SEPT9 DNA (mSEPT9) for detecting CRC in a screening population. Design Asymptomatic individuals ≥50 years old scheduled for screening colonoscopy at 32 US and German clinics voluntarily gave blood plasma samples before colon preparation. Using a commercially available assay, three independent blinded laboratories assayed plasma DNA of all CRC cases and a stratified random sample of other subjects in duplicate real time PCRs. The primary outcomes measures were standardised for overall sensitivity and specificity estimates. Results 7941 men (45%) and women (55%), mean age 60 years, enrolled. Results from 53 CRC cases and from 1457 subjects without CRC yielded a standardised sensitivity of 48.2% (95% CI 32.4% to 63.6%; crude rate 50.9%); for CRC stages I–IV, values were 35.0%, 63.0%, 46.0% and 77.4%, respectively. Specificity was 91.5% (95% CI 89.7% to 93.1%; crude rate 91.4%). Sensitivity for advanced adenomas was low (11.2%). Conclusions Our study using the blood based mSEPT9 test showed that CRC signal in blood can be detected in asymptomatic average risk individuals undergoing screening. However, the utility of the test for population screening for CRC will require improved sensitivity for detection of early cancers and advanced adenomas. Clinical Trial Registration Number: NCT00855348
Subfields: Cancer Research, Oncology, Pathology and Forensic Medicine
View Paper: https://www.semanticscholar.org/paper/fb490636c026e2ff8d9bb8045a11eb15957ca0a0
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Citations in the corpus
- Colorectal cancer screening for average‐risk adults: 2018 guideline update from the American Cancer Society (2018, methodology): “The USPSTF evidence report included one prospective study of mSept9 that showed a sensitivity and specificity of 48% and 91%, respectively, for detecting CRC in an average-risk population scheduled to undergo colonoscopy.(29,153) Since the USPSTF review, a retesting of samples from the same prospect”
- ACG Clinical Guidelines: Colorectal Cancer Screening 2021. (2021, methodology): “Based on recent SEER data, modeling studies (70) show similar benefit of CRC screening in African Americans and whites starting at age 45 years.”