• J P M Burbach, S A Kurk, Coebergh van den BraakR R JRRc Surgery , Erasmus University Medical Center , Rotterdam , The Netherlands., V K Dik, A M May, G A Meijer, C J A Punt, G R Vink, M Los, N Hoogerbrugge, P C Huijgens, J N M Ijzermans, E J Kuipers, M E de Noo, J P Pennings, A M T van der Velden, C Verhoef, P D Siersema, M G H van Oijen, H M Verkooijen, and M Koopman.
• a Radiation Oncology , UMC Utrecht , Utrecht , The Netherlands.
• Acta Oncol. 2016 Nov 1; 55 (11): 1273-1280.

BackgroundSystematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG).Methods/DesignThe Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria.ResultsSeven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients.ConclusionThis cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

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