Nationwide comprehensive gastro-intestinal cancer cohorts: The 3P initiative
van den Braak, R. R. J. Coebergh; van Rijssen, L. B.; van Kleef, J. J.; Vink, G. R.; Berbee, M.; Henegouwen, M. I. van Berge; Bloemendal, H. J.; Bruno, M. J.; Burgmans, M. C.; Busch, O. R. C.; Coene, P. P. L. O.; Coupe, V. M. H.; Dekker, J. W. T.; van Eijck, C. H. J.; Elferink, M. A. G.; Erdkamp, F. L. G.; van Grevenstein, W. M. U.; de Groot, J. W. B.; van Grieken, N. C. T.; de Hingh, I. H. J. T.; Hulshof, M. C. C. M.; Ijzermans, J. N. M.; Kwakkenbos, L.; Lemmens, V. E. P. P.; Los, M.; Meijer, G. A.; Molenaar, I. Q.; Nieuwenhuijzen, G. A. P.; de Noo, M. E.; van de Poll-Franse, L. V.; Punt, C. J. A.; Rietbroek, R. C.; Roeloffzen, W. W. H.; Rozema, T.; Ruurda, J. P.; van Sandick, J. W.; Schiphorst, A. H. W.; Schipper, H.; Siersema, P. D.; Slingerland, M.; Sommeijer, D. W.; Spaander, M. C. W.; Sprangers, M. A. G.; Stockmann, H. B. A. C.; Strijker, M.; van Tienhoven, G.; Timmermans, L. M.; Tjin-a-Ton, M. L. R.; van der Velden, A. M. T.; Verhaar, M. J.; Verkooijen, H. M.; Vles, W. J.; de Vos-Geelen, J. M. P. G. M.; Wilmink, J. W.; Zimmerman, D. D. E.; van Oijen, M. G. H.; Koopman, M.; Besselink, M. G. H.; van Laarhoven, H. W. M.
(2018) Acta Oncologica, volume 57, issue 2, pp. 195 - 202
(Article)
Abstract
Background: 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
... read more
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. Material and methods: 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. Results: 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 >85%. The number of hospitals participating in the cohorts is steadily increasing. Conclusion: 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.
show less
Download/Full Text
Keywords: Biological Specimen Banks, Cohort Studies, Gastrointestinal Neoplasms, Humans, Observational Studies as Topic/methods, Randomized Controlled Trials as Topic/methods, Registries, Research Design, Hematology, Oncology, Radiology Nuclear Medicine and imaging, Journal Article
ISSN: 0284-186X
Publisher: Informa Healthcare
Note: Funding Information: Financial support of the 3P initiative is based on ad hoc funding and structural funding. Ad hoc funding consists of public funds (e.g., the Dutch Cancer Society; The Netherlands Organization for Health Research, and Development) and public–private partnerships with pharmaceutical companies. These partnerships are increasingly popular to create the critical mass of partners in specific areas and allow to combine resources, expertise and complementary skills to advance the understanding of the factors underlying differences in the clinical outcome. Furthermore, these collaborations allow to develop drugs at a (possibly) lower cost and faster rate, and to evaluate the cost-effectiveness of new and costly medication [18]. Besides the financial support, the 3P initiative is also supported through data and knowledge-sharing, and access to information technology (IT) tools. Funding Information: PACAP is funded in part by a grant from the Dutch Cancer Society (Grant No. UVA 2013-5842). POCOP is funded in part by a grant from the Dutch Cancer Society (UVA 2014-7000). The biobank of PLCRC is supported by the Dutch Cancer Society (UVA 2013-6331). The 3P initiative is financially supported by Merck Netherlands B.V., Lilly Netherlands B.V., Bayer Netherlands B.V., and Roche Netherlands B.V. PLCRC is indirectly supported through several studies conducted within the infrastructure of PLCRC by Stand Up To Cancer (program of the Entertainment Industry Foundation administered by the American Association for Cancer Research), DCS International Translational Cancer Research Dream Team Grant (SU2C-AACR-DT1415), Servier Netherlands, Nutricia Advanced Medical Nutrition, and Syrtex Netherlands. Financial support of the 3P initiative is based on ad hoc funding and structural funding. Ad hoc funding consists of public funds (e.g., the Dutch Cancer Society; The Netherlands Organization for Health Research, and Development) and public?private partnerships with pharmaceutical companies. These partnerships are increasingly popular to create the critical mass of partners in specific areas and allow to combine resources, expertise and complementary skills to advance the understanding of the factors underlying differences in the clinical outcome. Furthermore, these collaborations allow to develop drugs at a (possibly) lower cost and faster rate, and to evaluate the cost-effectiveness of new and costly medication [18 ]. Besides the financial support, the 3P initiative is also supported through data and knowledge-sharing, and access to information technology (IT) tools. The Dutch Pancreas Biobank and Dutch Esophageal/Gastric Biobank are part of the Parelsnoer Institute (PSI), an initiative of the Dutch Federation of University Medical Centers (http://www.parelsnoer.org). Funding Information: PACAP is funded in part by a grant from the Dutch Cancer Society (Grant No. UVA 2013-5842). POCOP is funded in part by a grant from the Dutch Cancer Society (UVA 2014-7000). The biobank of PLCRC is supported by the Dutch Cancer Society (UVA 2013-6331). The 3P initiative is financially supported by Merck Netherlands B.V., Lilly Netherlands B.V., Bayer Netherlands B.V., and Roche Netherlands B.V. PLCRC is indirectly supported through several studies conducted within the infrastructure of PLCRC by Stand Up To Cancer (program of the Entertainment Industry Foundation administered by the American Association for Cancer Research), DCS International Translational Cancer Research Dream Team Grant (SU2C-AACR-DT1415), Servier Netherlands, Nutricia Advanced Medical Nutrition, and Syrtex Netherlands. Publisher Copyright: © 2017 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
(Peer reviewed)
