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Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer

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Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. / Church, Timothy Robert; Wandell, Michael; Lofton-Day, Catherine; Mongin, Steven J; Burger, Matthias; Payne, Shannon R; Castaños-Vélez, Esmeralda; Blumenstein, Brent A; Rösch, Thomas; Osborn, Neal; Snover, Dale; Day, Robert W; Ransohoff, David F; PRESEPT Clinical Study Steering Committee, Investigators and Study Team.

in: GUT, Jahrgang 63, Nr. 2, 01.02.2014, S. 317-325.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Church, TR, Wandell, M, Lofton-Day, C, Mongin, SJ, Burger, M, Payne, SR, Castaños-Vélez, E, Blumenstein, BA, Rösch, T, Osborn, N, Snover, D, Day, RW, Ransohoff, DF & PRESEPT Clinical Study Steering Committee, Investigators and Study Team 2014, 'Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer', GUT, Jg. 63, Nr. 2, S. 317-325. https://doi.org/10.1136/gutjnl-2012-304149

APA

Church, T. R., Wandell, M., Lofton-Day, C., Mongin, S. J., Burger, M., Payne, S. R., Castaños-Vélez, E., Blumenstein, B. A., Rösch, T., Osborn, N., Snover, D., Day, R. W., Ransohoff, D. F., & PRESEPT Clinical Study Steering Committee, Investigators and Study Team (2014). Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. GUT, 63(2), 317-325. https://doi.org/10.1136/gutjnl-2012-304149

Vancouver

Church TR, Wandell M, Lofton-Day C, Mongin SJ, Burger M, Payne SR et al. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. GUT. 2014 Feb 1;63(2):317-325. https://doi.org/10.1136/gutjnl-2012-304149

Bibtex

@article{b039de31b91c457d8f208296a1974da7,
title = "Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer",
abstract = "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.",
keywords = "Aged, Colorectal Neoplasms, DNA Methylation, Early Detection of Cancer, Female, Germany, Humans, Male, Mass Screening, Middle Aged, Prospective Studies, Sensitivity and Specificity, Septins, Tumor Markers, Biological, United States",
author = "Church, {Timothy Robert} and Michael Wandell and Catherine Lofton-Day and Mongin, {Steven J} and Matthias Burger and Payne, {Shannon R} and Esmeralda Casta{\~n}os-V{\'e}lez and Blumenstein, {Brent A} and Thomas R{\"o}sch and Neal Osborn and Dale Snover and Day, {Robert W} and Ransohoff, {David F} and {PRESEPT Clinical Study Steering Committee, Investigators and Study Team}",
year = "2014",
month = feb,
day = "1",
doi = "10.1136/gutjnl-2012-304149",
language = "English",
volume = "63",
pages = "317--325",
journal = "GUT",
issn = "0017-5749",
publisher = "BMJ PUBLISHING GROUP",
number = "2",

}

RIS

TY - JOUR

T1 - Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer

AU - Church, Timothy Robert

AU - Wandell, Michael

AU - Lofton-Day, Catherine

AU - Mongin, Steven J

AU - Burger, Matthias

AU - Payne, Shannon R

AU - Castaños-Vélez, Esmeralda

AU - Blumenstein, Brent A

AU - Rösch, Thomas

AU - Osborn, Neal

AU - Snover, Dale

AU - Day, Robert W

AU - Ransohoff, David F

AU - PRESEPT Clinical Study Steering Committee, Investigators and Study Team

PY - 2014/2/1

Y1 - 2014/2/1

N2 - 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.

AB - 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.

KW - Aged

KW - Colorectal Neoplasms

KW - DNA Methylation

KW - Early Detection of Cancer

KW - Female

KW - Germany

KW - Humans

KW - Male

KW - Mass Screening

KW - Middle Aged

KW - Prospective Studies

KW - Sensitivity and Specificity

KW - Septins

KW - Tumor Markers, Biological

KW - United States

U2 - 10.1136/gutjnl-2012-304149

DO - 10.1136/gutjnl-2012-304149

M3 - SCORING: Journal article

C2 - 23408352

VL - 63

SP - 317

EP - 325

JO - GUT

JF - GUT

SN - 0017-5749

IS - 2

ER -