van den Berg, I.
van de Weerd, S.
Roodhart, J. M. L.
Vink, G. R.
van den Braak, R. R. J. Coebergh
Jimenez, C. R.
Elias, S. G.
van Vliet, D.
Koelink, M.
Hong, E.
van Grevenstein, W. M. U.
van Oijen, M. G. H.
Beets-Tan, R. G. H.
van Krieken, J. H. J. M.
IJzermans, J. N. M.
Medema, J. P. http://orcid.org/0000-0003-3045-2924
Koopman, M.
,
Funding for this research was provided by:
KWF Kankerbestrijding (6331)
Article History
Received: 15 May 2020
Accepted: 29 July 2020
First Online: 18 August 2020
Ethics approval and consent to participate
: The study has been approved by the medical ethics committee Utrecht (MEC18/712). The medical ethics committee Utrecht belongs to the UMC Utrecht and the Prinses Máxima Center. Reference number SL/rc/19/009541. The study will be conducted according to the principles of the Declaration of Helsinki (10th version, Fortaleza 2013) and in concordance with the Dutch Medical Research Improving Human Subjects Act (WMO) and other applicable guidelines, regulations and acts.Authorships will be defined following the International Committee of Medical Journal Editors guidelines [CitationRef removed].The patients treating physicians, local investigator or research nurse of the participating hospitals will follow ICH-GCP and other applicable regulations in informing the patient and obtaining consent. This includes explaining the CONNECTION-II study to the patient, providing him/her with information such as the expected efficacy and possible side effects, and that refusal to participate will not influence further options for therapy. Before informed consent may be obtained, the investigator should provide the patient ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the patient. Only after written informed consent, the patient will be included in this study. The inclusion has to take place shortly after diagnosis to prevent delay in treatment.Patients are well informed that participation in voluntary and that they may withdraw at any point during the study.
: Not applicable.
: The authors declare that they have no competing interests.