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| |  Colon Cell-Collecting Device Could Aid Colorectal Cancer Screening: Presented at GASTRO 2009 (UEGW/WCOG) By Sara Freeman LONDON -- December 2, 2009 -- A novel device that enables the collection of exfoliated colonic epithelial cells could help clinicians identify people at risk of developing colorectal cancer (CRC) without the need for colonoscopy, according to data presented here at GASTRO 2009. “In the normal colon, there is very little colonocyte exfoliation that occurs, but that rate increases dramatically in the case of neoplasia,” said coinvestigator Lalitha Mahadavan, MBChB, MRCS(Ed), Royal Devon and Exeter Hospital, Devon, United Kingdom, speaking here on November 24. Dr. Mahadavan noted that these sloughed-off cells are found in the mucocellular layer of the gut and tend to migrate towards the rectum. Direct collection of exfoliated colonocytes from the surface of the mucosa can be achieved by inserting the colonic epithelial-cell collection device into a patient’s rectum and pushing a plunger to expand an inflatable balloon to capture the cells, which stick to the surface of the balloon. When the plunger is withdrawn, the cells are enclosed in a collection vessel that can be removed from the main device once it is removed from the patient. This device was used in 714 patients, of whom 71 (10%) had CRC. Colonocyte DNA scores were found to be significantly higher in patients with CRC than in those without CRC. When used in addition to other common screening investigations, the ability of this device to identify patients with CRC increased. The primary aim of the Comparison of Accuracy of Colonix in Colorectal Cancer in Exeter Region (CANCCER) Study was to look at the association between colonocyte DNA and CRC in a referred population of patients. Secondary aims were to estimate the colonic epithelial-cell collection device’s sensitivity and specificity, and to compare these to results obtained using clinical symptoms and the faecal occult blood test (FOB). Dr. Mahadavan reported that around 1,500 patients were referred by primary-care practices for investigation of possible CRC, and 828 were enrolled. Of these patients, 717 underwent screening with a symptom questionnaire, the colonic epithelial-cell collection device, FOB, and estimation of carcinoembryonic antigen (CEA), before colonoscopy or radiological imaging. Data on 714 patients were available for final analysis. All patients with CRC were offered appropriate treatment. There were 71 patients with CRC, with a mean age 73 years; 62% were male. The mean age of the 643 patients without CRC was 70 years; 57% were female. Mean DNA scores in patients with and without CRC were -7.8 and -4.4 ng/mL, respectively (P < .001). The odds ratio for each ng/mL increase in DNA score and the likelihood of CRC was 1.08 (95% confidence interval, 1.04-1.12), according to a univariate analysis. Further analysis showed that using the DNA score in combination with other investigations and parameters (ie, age, sex, mean cell volume, CEA, positive FOB, and rectal bleeding) increased the overall sensitivity and specificity of the colonic epithelial-cell collection device. “Colonocyte DNA obtained with the [collection] device has considerable ability to diagnose CRC within our referred population,” Dr. Mahadavan concluded. She added, “The [collection] device may be a useful diagnostic tool in the diagnosis of CRC in the future. It will perhaps be more acceptable as it imposes less restrictions on the patient when compared to colonoscopy.” Funding for this study was provided by Colonix Medical Ltd. GASTRO 2009 is jointly organised by the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED), and the British Society of Gastroenterology (BSG). [Presentation title: Preliminary Results From the Exeter CANCCER Study. Abstract OP285]
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