Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative
Creators: name: R. R. J. Coebergh Van Den Braak
name: L. B. Van Rijssen
name: J. J. Van Kleef
name: G. R. Vink
name: M. Berbee
name: M. I. Van Berge Henegouwen
name: H. J. Bloemendal
name: M. J. Bruno
name: M. C. Burgmans
name: O. R. C. Busch
name: P. P. L. O. Coene
name: V. M. H. Coupé
name: J. W. T. Dekker
name: C. H. J. Van Eijck
name: M. A. G. Elferink
name: F. L. G. Erdkamp
name: W. M. U. Van Grevenstein
name: J. W. B. De Groot
name: N. C. T. Van Grieken
name: I. H. J. T. De Hingh
name: M. C. C. M. Hulshof
name: J. N. M. Ijzermans
name: L. Kwakkenbos
name: V. E. P. P. Lemmens
name: M. Los
name: G. A. Meijer
name: I. Q. Molenaar
name: G. A. P. Nieuwenhuijzen
name: M. E. De Noo
name: L. V. Van De Poll-Franse
name: C. J. A. Punt
name: R. C. Rietbroek
name: W. W. H. Roeloffzen
name: T. Rozema
name: J. P. Ruurda
name: J. W. Van Sandick
name: A. H. W. Schiphorst
name: H. Schipper
name: P. D. Siersema
name: M. Slingerland
name: D. W. Sommeijer
name: M. C. W. Spaander
name: M. A. G. Sprangers
name: H. B. A. C. Stockmann
name: M. Strijker
name: G. Van Tienhoven
name: L. M. Timmermans
name: M. L. R. Tjin-A-Ton
name: A. M. T. Van Der Velden
name: M. J. Verhaar
name: H. M. Verkooijen
name: W. J. Vles
name: J. M. P. G. M. De Vos-Geelen
name: J. W. Wilmink
name: D. D. E. Zimmerman
name: M. G. H. Van Oijen
name: M. Koopman
name: M. G. H. Besselink
name: H. W. M. Van Laarhoven
Publisher: name: Taylor & Francis
Year: 2017
Subjects: subject: Medicine
subject: Genetics
subject: FOS: Biological sciences
subject: FOS: Biological sciences
subject: Biotechnology
subject: 39999 Chemical Sciences not elsewhere classified
subject: FOS: Chemical sciences
subject: FOS: Chemical sciences
subject: Immunology
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: 69999 Biological Sciences not elsewhere classified
subject: 80699 Information Systems not elsewhere classified
subject: FOS: Computer and information sciences
subject: FOS: Computer and information sciences
subject: Cancer
subject: Science Policy

description: <b>Background:</b> The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients. <b>Material and methods</b>: All patients aged ≥18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future. <b>Results:</b> In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was &gt;85%. The number of hospitals participating in the cohorts is steadily increasing. <b>Conclusion:</b> A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With this initiative, novel and innovative studies can be performed in an efficient, safe, and comprehensive setting.