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Authors
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Mackay, T. M. https://orcid.org/0000-0002-3730-6893
Smits, F. J.
Latenstein, A. E. J.
Bogte, A.
Bonsing, B. A.
Bos, H.
Bosscha, K.
Brosens, L. A. A.
Hol, L.
Busch, O. R. C.
Creemers, G. J.
Curvers, W. L.
den Dulk, M.
van Dieren, S.
van Driel, L. M. J. W.
Festen, S.
van Geenen, E. J. M.
van der Geest, L. G.
de Groot, D. J. A.
de Groot, J. W. B.
Haj Mohammad, N.
Haberkorn, B. C. M.
Haver, J. T.
van der Harst, E.
Hemmink, G. J. M.
de Hingh, I. H.
Hoge, C.
Homs, M. Y. V.
van Huijgevoort, N. C.
Jacobs, M. A. J. M.
Kerver, E. D.
Liem, M. S. L.
Los, M.
Lubbinge, H.
Luelmo, S. A. C.
de Meijer, V. E.
Mekenkamp, L.
Molenaar, I. Q.
van Oijen, M. G. H.
Patijn, G. A.
Quispel, R.
van Rijssen, L. B.
Römkens, T. E. H.
van Santvoort, H. C.
Schreinemakers, J. M. J.
Schut, H.
Seerden, T.
Stommel, M. W. J.
ten Tije, A. J.
Venneman, N. G.
Verdonk, R. C.
Verheij, J.
van Vilsteren, F. G. I.
de Vos-Geelen, J.
Vulink, A.
Wientjes, C.
Wit, F.
Wessels, F. J.
Zonderhuis, B.
van Werkhoven, C. H.
van Hooft, J. E.
van Eijck, C. H. J.
Wilmink, J. W.
van Laarhoven, H. W. M.
Besselink, M. G.
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Funding
Funding for this research was provided by:
KWF Kankerbestrijding (UVA2013-5842)
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Article History
Received: 22 December 2019
Accepted: 18 February 2020
First Online: 16 April 2020
Ethics approval and consent to participate {26a} {24}
: This trial is designed and will be conducted in accordance with the requirements of the Helsinki Declaration and Good Clinical Practice. The aim of PACAP-1 is to evaluate the effect of enhanced implementation of best practices for pancreatic cancer care. The interventions proposed are currently standard of care according to literature and guidelines, and for participation in PROMs only completing questionnaires is required. The focus of this trial was to educate and stimulate local clinicians to follow known best practice and optimize data registry. As this trial introduces nationwide implementation of best practices at the cluster level, all pancreatic cancer patients presenting in the DPCG centers and their region will participate. As patients in PACAP-1 are not subject to novel treatment and no precepts for behavior are imposed, this research does not fall under the Medical Research Involving Human Subjects Act (WMO). This was supported by the Medical Ethical Committee of the Amsterdam UMC, location AMC (December 18, 2017, W17_454#17.526). Ethics boards of all other participating centers approved of performing the PACAP-1 trial. Thus, informed consent of individual patients will not be asked specifically in PACAP-1. In addition, collection of PACAP-1 data will happen through existing encoded PACAP registries (i.e., DPCA, NCR, and PROMs) for which no informed consent is required. However, cluster consent of the pancreatic cancer team from every DPCG center was obtained [].
: Not applicable.
: Judith de Vos-Geelen has received non-financial support from Servier and has received institutional research funding from Servier, all outside the submitted work. Other authors declare that they have no competing interests.
