title: Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
authors: a Radiation Oncology , UMC Utrecht , Utrecht , The Netherlands.
authors: J P M
authors: JP
authors: Burbach
authors: b Medical Oncology , UMC Utrecht , Utrecht , The Netherlands.
authors: S A
authors: SA
authors: Kurk
authors: c Surgery , Erasmus University Medical Center , Rotterdam , The Netherlands.
authors: R R J
authors: RR
authors: Coebergh van den Braak
authors: d Gastro-Enterology , Meander Medical Center , Amersfoort , The Netherlands.
authors: V K
authors: VK
authors: Dik
authors: e Julius Center for Health Sciences and Primary Care, UMC Utrecht , Utrecht , The Netherlands.
authors: A M
authors: AM
authors: May
authors: f Pathology , Netherlands Cancer Institute , Amsterdam , The Netherlands.
authors: G A
authors: GA
authors: Meijer
authors: g Medical Oncology , Academic Medical Center, University of Amsterdam , The Netherlands.
authors: C J A
authors: CJ
authors: Punt
authors: h Netherlands Comprehensive Cancer Organisation , Utrecht , The Netherlands.
authors: G R
authors: GR
authors: Vink
authors: i Medical Oncology , St. Antonius Hospital , Nieuwegein , The Netherlands.
authors: M
authors: M
authors: Los
authors: j Genetics , Radboud University Medical Center , The Netherlands.
authors: N
authors: N
authors: Hoogerbrugge
authors: h Netherlands Comprehensive Cancer Organisation , Utrecht , The Netherlands.
authors: P C
authors: PC
authors: Huijgens
authors: c Surgery , Erasmus University Medical Center , Rotterdam , The Netherlands.
authors: J N M
authors: JN
authors: Ijzermans
authors: k Gastro-Enterology and Hepatology , Erasmus University Medical Center , Rotterdam , The Netherlands.
authors: E J
authors: EJ
authors: Kuipers
authors: l Surgery , Deventer Hospital , Deventer , The Netherlands.
authors: M E
authors: ME
authors: de Noo
authors: m Radiology , University Medical Center Groningen , The Netherlands.
authors: J P
authors: JP
authors: Pennings
authors: n Medical Oncology, Tergooi Hospital , Hilversum , The Netherlands.
authors: A M T
authors: AM
authors: van der Velden
authors: c Surgery , Erasmus University Medical Center , Rotterdam , The Netherlands.
authors: C
authors: C
authors: Verhoef
authors: o Gastro-Enterology , Radboud University Medical Center , Nijmegen , The Netherlands.
authors: P D
authors: PD
authors: Siersema
authors: g Medical Oncology , Academic Medical Center, University of Amsterdam , The Netherlands.
authors: M G H
authors: MG
authors: van Oijen
authors: p Trial Office Imaging Division , UMC Utrecht , Utrecht , The Netherlands.
authors: H M
authors: HM
authors: Verkooijen
authors: b Medical Oncology , UMC Utrecht , Utrecht , The Netherlands.
authors: M
authors: M
authors: Koopman
mesh_terms: D018070:Biological Specimen Banks; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000097:blood / Q000473:pathology*; D006801:Humans; D009426:Netherlands; D018579:Patient Selection; D011446:Prospective Studies; D011897:Random Allocation; D011795:Surveys and Questionnaires