Background: Systematic 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/design: The 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. Results: Seven 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. Conclusion: This 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.

To compare the accuracy of freehand versus robotic antenna placement in CT-guided microwave ablation (MWA) of liver tumors. Materials and Methods:This study was conducted as a prospective single-center nonblinded randomized controlled trial (Netherlands Trial Registry, NTR6023). Eligible study participants had undergone clinically indicated CT-guided MWA of liver tumors and were able to receive a CT contrast agent. Randomization was performed per tumor after identification on contrast material-enhanced CT images. The primary outcome was the number of antenna repositionings, which was compared by using the Mann-Whitney U test. Secondary outcomes were lateral targeting error stratified by in-plane and out-of-plane targets and targeting time.Results: Between February 14 and November 12, 2017, 31 participants with a mean age of 63 years (range, 25-88 years) were included: 17 women (mean age, 57 years; range, 25-77 years) and 14 men (mean age, 70 years; range, 52-88 years). The freehand study arm consisted of 19 participants, while the robotic study arm consisted of 18 participants; six participants with multiple tumors were included in both arms. Forty-seven tumors were assessed; five tumors were excluded from the analysis because of technical limitations. In the robotic arm, no antenna repositioning was required. In the freehand arm, a median of one repositioning was required (range, zero to seven repositionings; P , .001). For out-of-plane targets, lateral targeting error was 10.1 mm 6 4.0 and 5.9 mm 6 2.9 (P = .007) for freehand and robotic procedures, respectively, and for in-plane targets, lateral targeting error was 6.2 mm 6 2.7 and 7.7 mm 6 5.9, respectively (P = .51). Mean targeting time was 19 minutes (range, 8-55 minutes) and 36 minutes (range, 3-70 minutes; P = .001) for freehand and robotic procedures, respectively. Conclusion:Robotic antenna guidance reduces the need for antenna repositioning in microwave ablation to accurately target liver tumors and increases accuracy for out-of-plane targets. However, targeting time was greater with robotic guidance than with freehand targeting.

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acknowledgements We acknowledge and thank the patients who participated in this study and the contribution of the personnel working at the endoscopy suite, the surgical theatre and the pathology department for their assistance at all study procedures. Special thanks to W Boersma-van Ek for her technical assistance in the laboratory.