Ethic approval and consent to participate
MAY
The study is conducted according to the international standards of the International Council for Harmonisation (ICH)/Good Clinical Practice (GCP), monitored by the independent Danish GCP Units, and in full conformance with the “Declaration of Helsinki” and the Danish laws and regulations. The protocol is approved by the Danish Ethics Committee (VEK nr. N-20210068); date of approval: 16 of May 2023, the Danish Data Protection Agency (F2022-028; 22 of March 2022) and the Danish Medicines Agency (EudraCT 2021–005067-52). Protocol amendments and modifications will be submitted for approval to the competent authorities and all relevant collaborators will be informed by the trial coordinating team.Eligible patients will be given oral and written information about the trial by the sponsor, investigator or a designated oncologist with GCP experience. Participation in the study is entirely voluntary. If the patient declines participation, this will not have any consequences or lack of opportunities for any other treatment of the patient. No remuneration will be paid to the patients for participation.The data for the study is collected and managed using the secure and encrypted, web-based REDCap electronic data capture tools [