A new minimally invasive cell sampling device coupled with assessment of trefoil factor 3 expression can be used to identify patients with reflux symptoms who warrant endoscopy to diagnose Barrett's esophagus, according to a study published by Rebecca Fitzgerald and colleagues from the MRC Cancer Unit, UK, in this week's PLOS Medicine.
To evaluate the safety, acceptability, and accuracy of the minimally invasive test compared with endoscopy for the diagnosis of Barrett's esophagus, the researchers enrolled 1110 individuals attending 11 UK hospitals for investigational endoscopy of dyspepsia and reflux symptoms. They found that the new test correctly identified 79.9% of the 647 individuals with endoscopically diagnosed Barrett's esophagus, and that 92.4% of 463 individuals unaffected by Barrett's esophagus were correctly identified as being unaffected. The sensitivity of the test increased to 87.2% for patients with circumferential Barrett's segments more than 3 cm, which are known to confer a higher cancer risk. Nearly 94% of the participants swallowed the sampling device (Cytosponge) successfully, there were no adverse effects attributed to the device, and participants who swallowed the device generally rated the experience as acceptable.
While the findings indicate that this new cell sampling device might provide a simple, minimally invasive way to identify those patients with reflux symptoms who warrant endoscopy to diagnose Barrett's esophagus, randomized controlled trials of the test are needed to assess its suitability for clinical implementation. Moreover, because most people with Barrett's esophagus never develop esophageal cancer, additional biomarkers ideally need to be added to the test to identify those individuals who have the greatest risk of esophageal cancer, and thereby avoid overtreatment of Barrett's esophagus.
The authors say: "The Cytosponge-TFF3 test can diagnose [Barrett's esophagus] in a manner that is acceptable to patients and logistically feasible across multiple centers. This test may substantially lower the threshold for investigating patients with reflux, as part of a strategy to reduce population mortality from esophageal adenocarcinoma."
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Research Article
Funding: The BEST2 study was funded by Cancer Research UK in its entirety (Grant ref; C14478/A12088, http://www.cancerresearchuk.org/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: The Addenbrooke's Hospital Human Research Tissue Bank, supported by the NIHR Cambridge Biomedical Research Centre, supported this study. This study was funded by a project grant from Cancer Research UK. The device was designed by RCF and her research team in between 2009 and 2010. Patents and a trademark were filed in 2010 by the Medical Research Council (MRC). The BEST2 study was designed in 2010 and the device was manufactured for the specific purpose of this study following a letter of no objection from the Medical Health Regulatory Agency. In 2013 the MRC licensed the technology to Covidien GI Solutions. They have had no influence in any way on the design, conduct or analysis of this trial and the manuscript was not disclosed to them until after acceptance for publication. RCF, MOD and PLS are named inventors on patents pertaining to the Cytosponge and related assays. They have not received any financial benefits to date. Since December 2013, after completion of this study, PLS is now employed partly by Covidien GI Solutions. All other authors have no conflicts of interest to declare. RCF has programmatic funding from the Medical Research Council and infrastructure support from the Biomedical Research Centre and the Experimental Medicine Centre. MDDR has received travel reimbursement for conferences (Abbvie 2014), honoraria (Dr Falk 2013), unrestricted grant research (Olympus 2014) and shares (AstraZeneca, held for >20 years).
Citation: Ross-Innes CS, Debiram-Beecham I, O'Donovan M, Walker E, Varghese S, Lao-Sirieix P, et al. (2015) Evaluation of a Minimally Invasive Cell Sampling Device Coupled with Assessment of Trefoil Factor 3 Expression for Diagnosing Barrett's's Esophagus: A Multi-Center Case-Control Study. PLoS Med 12(1): e1001780. doi:10.1371/journal.pmed.1001780
Author Affiliations:
MRC Research Centre, University of Cambridge, UNITED KINGDOM
Addenbrooke's Hospital, UNITED KINGDOM
University College London Hospital, UNITED KINGDOM
Royal Victoria Infirmary, UNITED KINGDOM
Nottingham Queen's Medical Centre, UNITED KINGDOM
Cancer Prevention Trials Unit, UNITED KINGDOM
Queen Alexandra Hospital, UNITED KINGDOM
St. Mark's Hospital, UNITED KINGDOM
East and North Hertfordshire NHS Trust-QEII and Lister Hospitals, UNITED KINGDOM
Northern Region Endoscopy Group, UNITED KINGDOM
North Tyneside General Hospital, UNITED KINGDOM
County Durham and Darlington NHS Foundation Trust, UNITED KINGDOM
South Tyneside NHS Foundation Trust, UNITED KINGDOM
North Tees and Hartlepool NHS Foundation Trust, UNITED KINGDOM
Contact:
Rebecca C. Fitzgerald
University of Cambridge
UNITED KINGDOM
+44 1223 763 292
rcf29@mrc-cu.cam.ac.uk
Journal
PLoS Medicine