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BMC Cancer
Published in: BMC Cancer 1/2017

Open Access 01-12-2017 | Study protocol

Molecular stool testing as an alternative for surveillance colonoscopy: a cross-sectional cohort study

Authors: Meta C. J. van Lanschot, Beatriz Carvalho, Veerle M. H. Coupé, Manon van Engeland, Evelien Dekker, Gerrit A. Meijer

Published in: BMC Cancer | Issue 1/2017

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Abstract

Background

As in many other European countries, a nationwide screening program for colorectal cancer (CRC) has recently been introduced in the Netherlands. As a side effect, such a screening program will inherently yield an increase in the demand for surveillance after removal of polyps/adenomas or CRC. Although these patients are at increased risk of metachronous colorectal neoplasia, solid evidence on CRC-related mortality reduction as a result of colonoscopy-based surveillance programs is lacking. Furthermore, colonoscopy-based surveillance leads to high patient burden, high logistic demands and high costs. Therefore, new surveillance strategies are needed. The aim of the present study, named Molecular stool testing for Colorectal CAncer Surveillance (MOCCAS), is to determine the performance characteristics of two established non-invasive tests, i.e., the multitarget stool DNA test Cologuard® and the faecal immunochemical test (FIT) in the detection of CRC and advanced adenomas as an alternative for colonoscopy surveillance.

Methods

In this observational cross-sectional cohort study, subjects aged 50 to 75 years will be approached to collect (whole-) stool samples for molecular testing and a FIT prior to their scheduled surveillance colonoscopy. The results of the tests will allow calculation of test sensitivities and specificities in the context of surveillance. This will provide the required input for the Dutch ASCCA model (Adenoma and Serrated pathway to Colorectal CAncer) to simulate surveillance strategies differing in frequency and duration. The model will allow predictions of lifetime health effects and costs. Multiple centres in the Netherlands will participate in the study that aims to include 4,000 individuals.

Discussion

The outcome of this study will inform on the (cost-) effectiveness of stool based molecular testing as an alternative for colonoscopy in the rapidly expanding surveillance population.

Trial registration

ClinicalTrials.gov (https://​clinicaltrials.​gov/​): NCT02715141. Retrospectively registered 17 February 2016.
Literature
1.
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics: 2011. CA Cancer J Clin. 2011;61:69–90.CrossRefPubMed
2.
3.
Atkin WS, Morson BC, Cuzick J. Long-term risk of colorectal cancer after excision of rectosigmoid adenomas. N Engl J Med. 1992;326:658–62.CrossRefPubMed
4.
Ginsberg GM, Lim SS, Lauer JA, Johns BP, Sepulveda CR. Prevention, screening and treatment of colorectal cancer: a global and regional generalized cost effectiveness analysis. Cost Eff Resour Alloc. 2010;8:1–16.CrossRef
5.
Shaukat A, Mongin SJ, Geisser MS, Lederle FA, Bond JH, Mandel JSCT. Long-term mortality after screening for colorectal cancer. N Engl J Med. 2013;19:1106–14.CrossRef
6.
Kronborg O, Fenger C, Olsen J, Jørgensen OD, Søndergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996;348:1467–71.CrossRefPubMed
7.
Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996;348:1472–7.CrossRefPubMed
8.
Toes-Zoutendijk E, van Leerdam ME, Dekker E, van Hees F, Penning C, Nagtegaal I, van der Meulen MP, van Vuuren AJ, Kuipers EJ, Bonfrer JM, Biermann K, Thomeer MG, van Veldhuizen H, Kroep S, van Ballegooijen M, Meijer GA, de Koning HJ, Spaander MC, Lansdorp-Vogelaar I; Dutch National Colorectal Cancer Screening Working Group. Real-Time Monitoring of Results During First Year of Dutch Colorectal Cancer Screening Program and Optimization by Altering Fecal Immunochemical Test Cut-Off Levels. Gastroenterology. 2016 Nov 24. doi:10.​1053/​j.​gastro.​2016.​11.​022. [Epub ahead of print].
9.
Yamaji Y, Mitsushima T, Ikuma H, Watabe H, Okamoto M, Kawabe T, Wada R, Doi H, Omata M. Incidence and recurrence rates of colorectal adenomas estimated by annually repeated colonoscopies on asymptomatic Japanese. Gut. 2004;53:568–72.CrossRefPubMedPubMedCentral
10.
Robertson DJ, Greenberg ER, Beach M, Sandler RS, Ahnen D, Haile RW, Burke CA, Snover DC, Bresalier RS, McKeown-Eyssen G, Mandel JS, Bond JH, Van Stolk RU, Summers RW, Rothstein R, Church TR, Cole BF, Byers T, Mott L, Baron JA. Colorectal cancer in patients under close colonoscopic surveillance. Gastroenterology. 2005;129:34–41.CrossRefPubMed
11.
Loeve F, van Ballegooijen M, Boer R, Kuipers EJ, Habbema JDF. Colorectal cancer risk in adenoma patients: a nation-wide study. Int J Cancer. 2004;111:147–51.CrossRefPubMed
12.
Cottet V, Jooste V, Fournel I, Bouvier AM, Faivre J, Bonithon-Kopp C. Long-term risk of colorectal cancer after adenoma removal: a population-based cohort study. Gut. 2012;61:1180–6.CrossRefPubMed
13.
Hassan C, Quintero E, Dumonceau J-M, Regula J, Brandão C, Chaussade S, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gimeno-García A, Hazewinkel Y, Jover R, Kalager M, Loberg M, Pox C, Rembacken B, Lieberman D. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45:842–51.CrossRefPubMed
14.
Rex DK, Kahi CJ, Levin B, Smith RA, Bond JH, Brooks D, Burt RW, Byers T, Fletcher RH, Hyman N, Johnson D, Kirk L, Lieberman DA, Levin TR, O’Brien MJ, Simmang C, Thorson AG, Winawer SJ. Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and the US multi-society task force on colorectal cancer. Gastroenterology. 2006;130:1865–71.CrossRefPubMed
15.
16.
Brenner H, Chang-Claude J, Rickert A, Seiler CM, Hoffmeister M. Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study. J Clin Oncol. 2012;30:2969–76.CrossRefPubMed
17.
Lieberman DA, Weiss DG, Bond JH, Ahnen DJ, Garewal H, Chejfec G. Use of colonoscopy to screen asymptomatic adults for colorectal cancer. Veterans affairs cooperative study group 380. N Engl J Med. 2000;343:162–8.CrossRefPubMed
18.
Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Risk of advanced proximal neoplasms in asymptomatic adults according to the distal colorectal findings. N Engl J Med. 2000;343:169–74.CrossRefPubMed
19.
20.
Hisabe T, Tsuda S, Matsui T, Iwashita A. Natural history of small colorectal protuberant adenomas. Dig Endosc. 2010;22 Suppl 1:S43–6.CrossRefPubMed
21.
Tutein Nolthenius CJ, Boellaard TN, de Haan MC, Nio CY, Thomeer MGJ, Bipat S, van Swijndregt AD M, van de Vijver MJ, Biermann K, Kuipers EJ, Dekker E, Stoker J. Evolution of screen-detected small (6–9 mm) polyps after a 3-year surveillance interval: assessment of growth with CT colonography compared with histopathology. Am J Gastroenterol. 2015;110:1682–90.CrossRefPubMed
22.
Sint Nicolaas J, de Jonge V, van Baalen O, Kubben FJGM, Moolenaar W, Stolk MFJ, Kuipers EJ, van Leerdam ME. Optimal resource allocation in colonoscopy: timing of follow-up colonoscopies in relation to adenoma detection rates. Endoscopy. 2013;45:545–52.CrossRefPubMed
23.
Jonkers D, Ernst J, Pladdet I, Stockbrugger R, Hameeteman W. Endoscopic follow-up of 383 patients with colorectal adenoma: an observational study in daily practice. Eur J Cancer Prev. 2006;15:202–10.CrossRefPubMed
24.
Lane JM, Chow E, Young GP, Good N, Smith A, Bull J, Sandford J, Morcom J, Bampton PA, Cole SR. Interval fecal immunochemical testing in a colonoscopic surveillance program speeds detection of colorectal neoplasia. Gastroenterology. 2010;139:1918–26.CrossRefPubMed
25.
Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas Á, Andreu M, Carballo F, Morillas JD, Hernández C, Jover R, Montalvo I, Arenas J, Laredo E, Hernández V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andrés M, Teruel G, Peris A, Roncales M-P, Polo-Tomás M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, et al. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012;366:697–706.CrossRefPubMed
26.
Morikawa T, Kato J, Yamaji Y, Wada R, Mitsushima T, Shiratori Y. A comparison of the immunochemical fecal occult blood test and total colonoscopy in the asymptomatic population. Gastroenterology. 2016;129:422–8.CrossRef
27.
Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370:1287–97.CrossRefPubMed
28.
Stoop EM, de Haan MC, de Wijkerslooth TR, Bossuyt PM, van Ballegooijen M, Nio CY, van de Vijver MJ, Biermann K, Thomeer M, van Leerdam ME, Fockens P, Stoker J, Kuipers EJ, Dekker E. Participation and yield of colonoscopy versus non-cathartic CT colonography in population-based screening for colorectal cancer: a randomised controlled trial. Lancet Oncol. 2012;13:55–64.CrossRefPubMed
29.
Hermsen M, Postma C, Baak J, Weiss M, Rapallo A, Sciutto A, Roemen G, Arends J, Williams R, Giaretti W, De Goeij A, Meijer G. Colorectal adenoma to carcinoma progression follows multiple pathways of chromosomal instability. Gastroenterology. 2002;123:1109–19.CrossRefPubMed
30.
Stegeman I, de Wijkerslooth TR, Stoop EM, van Leerdam ME, Dekker E, van Ballegooijen M, Kuipers EJ, Fockens P, Kraaijenhagen RA, Bossuyt PM. Colorectal cancer risk factors in the detection of advanced adenoma and colorectal cancer. Cancer Epidemiol. 2013;37:278–83.CrossRefPubMed
31.
Stegeman I, de Wijkerslooth TR, Stoop EM, van Leerdam ME, Dekker E, van Ballegooijen M, Kuipers EJ, Fockens P, Kraaijenhagen RA, Bossuyt PM. Combining risk factors with faecal immunochemical test outcome for selecting CRC screenees for colonoscopy. Gut. 2014;63:466–71.CrossRefPubMed
32.
Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015;110:72–90.CrossRefPubMed
33.
Lieberman D, Nadel M, Smith RA, Atkin W, Duggirala SB, Fletcher R, Glick SN, Johnson CD, Levin TR, Pope JB, Potter MB, Ransohoff D, Rex D, Schoen R, Schroy P, Winawer S. Standardized colonoscopy reporting and data system: report of the quality assurance task group of the national colorectal cancer roundtable. Gastrointest Endosc. 2007;65:757–66.CrossRefPubMed
34.
Edger SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A. AJCC Cancer Staging Manual, 7th ed. New York: Springer; 2010.
35.
36.
37.
Ahlquist DA, Zou H, Domanico M, Mahoney DW, Yab TC, Taylor WR, Butz ML, Thibodeau SN, Rabeneck L, Paszat LF, Kinzler KW, Vogelstein B, Bjerregaard NC, Laurberg S, Sørensen HT, Berger BM, Lidgard GP. Next-generation stool DNA test accurately detects colorectal cancer and large adenomas. Gastroenterology. 2012;142:248–56. quiz e25–6.CrossRefPubMed
38.
Hol L, van Leerdam ME, van Ballegooijen M, van Vuuren AJ, van Dekken H, Reijerink JCIY, van der Togt ACM, Habbema JDF, Kuipers EJ. Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy. Gut. 2010;59:62–8.CrossRefPubMed
Metadata
Title
Molecular stool testing as an alternative for surveillance colonoscopy: a cross-sectional cohort study
Authors
Meta C. J. van Lanschot
Beatriz Carvalho
Veerle M. H. Coupé
Manon van Engeland
Evelien Dekker
Gerrit A. Meijer
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2017
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-017-3078-y

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