Litjens, G.
Rivière, D. M.
van Geenen, E. J. M.
Radema, S. A.
Brosens, L. A. A.
Prokop, M.
van Laarhoven, C. J. H. M.
Hermans, J. J. http://orcid.org/0000-0001-9207-0548
Funding for this research was provided by:
KWF Kankerbestrijding (10224)
Article History
Received: 22 June 2020
Accepted: 28 July 2020
First Online: 10 August 2020
Ethics approval and consent to participate
: The DIA-PANC study will be conducted according to the principles of the Declaration of Helsinki (64th version, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO). The independent ethics review board region Arnhem-Nijmegen (Nijmegen, The Netherlands) has approved the trial protocol (NL60473.091.17). Furthermore, secondary approval for all participating centers from The Netherlands was or will be individually obtained from all local ethics committees. According to Dutch law, ethical approval by the ethics review board of the study sponsor (i.e. initiating center, Radboudumc, Nijmegen, The Netherlands) is appropriate for all Dutch centers. For all participating centers outside of The Netherlands approval from a local independent ethics review board was or will be obtained. The trial is registered in the registry provided by the U.S. National Library of Medicine (ExternalRef removed) with identification number NCT03469726. Patients can only participate if written informed consent has been provided.Protocol modifications will be communicated to all relevant parties (e.g. participating centers, funder) after approval of the ethical committee and will be updated in the trial registry. Possible substudies, like Biobank (samples will be stored at the Radboud Biobank) or artificial intelligence analysis, are included on the informed consent form. Patients must give separate consent to participate in these substudies. The study will be monitored according to the guidelines of The Netherlands Federation of University Medical Centres (NFU) and adverse events related to study procedures will be recorded. There is a study subject insurance for patients that suffer harm from trial participation.
: Not applicable.
: The authors declare that they have no competing interests.