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


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov ( https://clinicaltrials.gov/ ): NCT02715141 . Retrospectively registered 17 February 2016.
Department of Pathology, The Netherlands Cancer Institute, Plesmanlaan 121 1066 CX, Amsterdam, The Netherlands.|Department of Gastroenterology and Hepatology, Academic Medical Center, Meibergdreef 9 1105 AZ, Amsterdam, The Netherlands.
Meta C J
MC
van Lanschot
Department of Pathology, The Netherlands Cancer Institute, Plesmanlaan 121 1066 CX, Amsterdam, The Netherlands.
Beatriz
B
Carvalho
Department of Epidemiology and Biostatistics, VU medical center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands.
Veerle M H
VM
Coupé
GROW-School for Oncology and Developmental Biology, Maastricht University Medical Center, Universiteitssingel 40 6229 ER, Maastricht, The Netherlands.
Manon
M
van Engeland
Department of Gastroenterology and Hepatology, Academic Medical Center, Meibergdreef 9 1105 AZ, Amsterdam, The Netherlands.
Evelien
E
Dekker
Department of Pathology, The Netherlands Cancer Institute, Plesmanlaan 121 1066 CX, Amsterdam, The Netherlands. g.meijer@nki.nl.
Gerrit A
GA
Meijer
D000236:Adenoma / Q000175:diagnosis* / Q000378:metabolism / Q000473:pathology; D000368:Aged; D015331:Cohort Studies; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000378:metabolism / Q000473:pathology; D003430:Cross-Sectional Studies; D004273:DNA, Neoplasm / Q000032:analysis*; D055088:Early Detection of Cancer / Q000191:economics / Q000379:methods*; D005243:Feces / Q000737:chemistry*; D006801:Humans; D007120:Immunochemistry; D008875:Middle Aged; D009426:Netherlands; D012107:Research Design; D012680:Sensitivity and Specificity
D004273:DNA, Neoplasm
Cologuard®; Colorectal cancer; FIT; Multitarget stool DNA testing; Polypectomy; Surveillance