ColonSentry® is a minimally invasive, blood-based risk assessment test for colorectal cancer. The test is used to increase patient compliance with colonoscopy. Many physicians have inquired about the incidence of non-malignant lesions found in patients after colonoscopy prompted by an increased risk score on the ColonSentry test. Here we report on the colonoscopy results of five patients with increased ColonSentry risk scores. Of those five patients, three were determined to have polyps, one of which was pre-malignant

Burakoff, Robert

Das, Prashanta Kumar

Harris, David Frederick

Lee, Michelle Mei  Lin

Liew, Choong-Chin

Lim, Chun Ren

Seow, Eng Lok

Sim, Mohamad Hasyim Mohd Sharil

English

CSCanada.net: E-Journals (Canadian Academy of Oriental and Occidental Culture, Canadian Research & Development Center of Sciences and Cultures)

8 ISSN  1925-9611[Print]ISSN 1925-962X[Online]   www.cscanada.netwww.cscanada.orgGastroenterology and HepatologyVol. 1, No. 1, 2014, pp. 8-10DOI: 10.3968/5262Copyright © Canadian Research & Development Center of Sciences and CulturesIncreasing Colonoscopy Compliance Using a Blood-Based Risk Assessment Test for Colorectal CancerChun Ren Lim[a]; Mohamad Hasyim Mohd Sharil Sim[b]; Eng Lok Seow[c]; Prashanta Kumar Das[d]; David Frederick Harris[e]; Michelle Mei Lin Lee[f]; Choong-Chin Liew[g],*; Robert Burakoff[h].[a] Ph.D., GeneNews (Malaysia) Limited 23 Jalan Bulan, Tanjung Bungah 11200, Penang Malaysia.[b] MSc, GeneNews Diagnostics Sdn. Bhd. Office/Lab 9, Biotechnology Incubation Centre, Technology Park Malaysia Lebuhraya Puchong-Sg. Besi, Bukit Jalil, 57000 Kuala Lumpur, Malaysia.[c] MD, Island Hospital 308 Macalister Road, 10450 Penang, Malaysia.[d] MD, Lam Wah Ee Hospital Jalan Tan Sri Teh Ewe Lim, 11600 Georgetown, Penang, Malaysia.[e] MD, GeneNews Diagnostics Sdn. Bhd. Office/Lab 9, Biotechnology Incubation Centre, Technology Park Malaysia, Lebuhraya Puchong-Sg. Besi, Bukit Jalil, 57000 Kuala Lumpur, Malaysia.[f] MSc, GeneNews (Malaysia) Limited 23 Jalan Bulan, Tanjung Bungah 11200, Penang Malaysia.[g] Ph.D., GoldenHealth Diagnostics 81 Millersgrove Drive North York, Ontario, M2R 3S1.[h] MD,  Brigham and Women’s Hospital, Harvard Medical School , 75 Francis St, Suite 11, Boston, Massachusetts 02115, United States of America.*Corresponding Author.Received July 12, 2014; accepted August 15, 2014Published online August 26, 2014AbstractColonSentry® is a minimally invasive, blood-based risk assessment test for colorectal cancer. The test is used to increase patient compliance with colonoscopy. Many physicians have inquired about the incidence of non-malignant lesions found in patients after colonoscopy prompted by an increased risk score on the ColonSentry test. Here we report on the colonoscopy results of five patients with increased ColonSentry risk scores. Of those five patients, three were determined to have polyps, one of which was pre-malignant.Key words: ColonSentry； Colorectal cancer； Biomarkers; ColonoscopyLim,  C.  R. ,  Sim,  M. ,  Seow,  E.  L. ,   Das ,  P.  K. ,  Harr is ,  D. F. ,   Lee ,  M.  M.  L . ,  L iew,  C.  C. ,  &  Burakoff ,  R .  (2014) . Title. Canadian Social Science,  10 (6), 8-10. Available from: h t tp : / /www.cscanada .ne t / index .php /css / a r t i c l e /v iew/5262 DOI: http://dx.doi.org/10.3968/5262INTRODUCTIONColorectal cancer is the world’s third most common cancer and the fourth most common cause of global cancer death[1]. Early detection of colorectal cancer through screening can increase 5-year survival rates to 90% [2]. The gold standard for colorectal cancer screening is colonoscopy. However, this procedure is inconvenient and not without risks. Colonoscopy requires bowel preparation, and patients need to take time off work. Minor risks are common; approximately one-third of patients having colonscopy report minor gastrointestinal symptoms. Rare but serious complications, including bowel perforation, have been estimated to occur approximately 2.8 times per 1000 screening colonoscopy procedures carried out in average-risk populations[3]. As a result, many patients are reluctant to undergo colonoscopies, and screening compliance for colorectal cancer is less than for other malignancies such as breast cancer[1].ColonSentry is a pre-screening blood-based test developed by GeneNews Ltd. The test is convenient and patient friendly, requires no bowel preparation or dietary restrictions and, since it is a simple blood test, carries minimal risks of complications. ColonSentry measures the gene expression profile of 7 genes. Those patients who present with an above-average risk score for colorectal cancer can then be referred for colonoscopy[4-5].Materials & MethodsColonSentry blood samples were collected from patients in Malaysia between 6 June 2011 and 29 August 2013; 250 Malaysian patients had the ColonSentry test. Samples were collected using PaxGene tubes (PreAnalytix, Hombrechtikon, Switzerland). Whole blood RNA was isolated as described previously[4].  Isolated RNA was checked using 2100 Bioanalyzer RNA 6000 Nano Chips (Agilent Technologies, CA). RNA quantity was determined by absorbance at 260nm with a NanoDrop 9 Copyright © Canadian Research & Development Center of Sciences and CulturesChun Ren Lim; Mohamad Hasyim Mohd Sharil Sim; Eng Lok Seow; Prashanta Kumar Das; David Frederick Harris; Michelle Mei Lin Lee; Choong-Chin Liew; Robert Burakoff (2014). Gastroenterology and Hepatology, 1(1), 8-102000c UV-vis Spectrophotometer  (Thermo Scientific, DE).Quantitative reverse-transcription real-time RT-PCR reaction procedures for the seven gene biomarkers have been described previously[4].  Briefly, one microgram of RNA was reverse transcribed into single-stranded complementary DNA (cDNA) using the High Capacity cDNA Reverse Transcription Kit (Applied Biosystems) in 1X RT reaction. For qPCR, 20 ng cDNA was mixed with Quantitect® Probe PCR Master Mix (Qiagen) and Taqman® dual-labeled probe and primers corresponding to the gene of interest and reference gene, in a 25 µL reaction volume. PCR amplification was performed using a 7500 Real-Time PCR System (Applied Biosystems). Sixty-seven patients who had taken the ColonSentry test were identified as being at or above a 2-fold increased risk for colorectal cancer and were referred for colonoscopy. These patients were asked to provide their colonoscopy results to us if they were going to have a colonoscopy after our ColonSentry test. RESULTSFrom 6 June 2011 to 29 August 2013, 250 Malaysian patients took a ColonSentry blood test. Sixty-seven of those patients were identified as being at or above a 2-fold increased risk for colorectal cancer and were referred for colonoscopy.Patient Follow-Up and Colonoscopy ResultsBy 01 September 2013, 5 of the patients had submitted their colonoscopy results to us (Table 1).  Table 1Colonoscopy and ColonSentry® Test Results for the Five Patients Who Have Submitted Their Colonoscopy ResultsPatient ID Gender Age ColonSentry®risk score Colonoscopy & pathology resultsGND100343 M 73 + 7.7X Two sessile polyps not sentto pathologyGND100345 F 64 > + 10.0X Normal colonoscopyGND100053 F 53 + 8.4X Benign hyperplastic polypGND100055 M 56 + 7.7X Normal colonoscopyGND100220 M 42 + 4.2XFour polyps:1 moderately atypical tubular  adenoma3 benign polypsDiscussionOf the 67 high risk patients referred for colonoscopy, 5 patients submitted their colonoscopy results to us for analysis. Sixty-two patients did not submit their results (if any) to us. Of the 5 patients, 3 were found to have polyps, including 1 patient who had a premalignant, moderately atypical tubular adenoma (Figure 1). Increasing Colonoscopy Compliance Using a Blood-Based Risk Assessment Test for Colorectal CancerCopyright © Canadian Research & Development Center of Sciences and Cultures10Figure 1Patient GND100220: Colonoscopy report and imagesThese findings indicate that the ColonSentry test can predict the presence of non-malignant colorectal lesions as well as the presence of colorectal cancer. Currently, only a few results have been made available to us, as only five patients have given us their colonoscopy results. The remaining 62  patients with an increased-risk score have not provided us with their colonoscopy  results. As more increased-risk patients submit their colonoscopy results to us, we expect to extend these preliminary findings.In a previous paper published in 2010 we identified the 7-gene biomarker panel, which forms the basis of the ColonSentry test,  and we discuss these genes in that report (4). These biomarkers are probably not conventional cancer biomarkers but rather are subtle, systemic alterations in blood gene expression in response to disease.CONCLUSIONBased on the above preliminary findings, the ColonSentry test may be able to predict the presence of polyps, including pre-malignant polyps. This should provide a Pathology ObservationPolyp 1. Mucous of ileum. No atypism in glandular epithelium. At mesenchyma, assembly of lymphoid follicles-like cells. Infiltrated lymph showed no atypism.Polyp 2. In the mucous, proliferation of moderate atypical tubular adenoma (premalignantpolyp) could be observed. Polyps  3 and 4.  Extensive formation of polyps.further impetus for patients with an elevated risk score on the ColonSentry test to proceed to colonoscopy.REFERENCES[1] Hagga, F. A., & Boushey, R. P. (2009). Colorectal cancer epidemiology: Incidence, mortality, survival and risk factors. Clinics in Colon and Rectal Surgery, 22(4), 191- 197.[2] American Cancer Society. (2011). Colorectal Cancer Facts & Figures 2011— 2013. Atlanta: American Cancer Society.[3] American Society for Gastrointestinal Endoscopy. (2011). Complications of Colonoscopy. Gastrointestinal Endoscopy, 74, 745-752.[4] Marshall, K.W., Mohr, S., Khettabi, F. E., Nossova, N., Chao, S., Bao, W.,…Liew, C. C. (2010). A blood-based biomarker panel for stratifying current risk for colorectal cancer. International Journal of Cancer, 126, 1177-1186.[5] Yip, K.T., Das, P. K., Suria, D., Lim, C. R., Ng, G. H. & Liew, C. C. (2010) A case-controlled validation study of a blood-based seven-gene biomarker panel for colorectal cancer in Malaysia. Journal of Experimental & Clinical Cancer Research, 29, 128-134.

Increasing Colonoscopy Compliance Using a Blood-Based Risk Assessment Test for Colorectal Cancer

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Increasing Colonoscopy Compliance Using a Blood-Based Risk Assessment Test for Colorectal Cancer

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