Rasmussen, Louise Skau
Winther, Stine B.
Chen, Inna M.
Weber, Britta
Ventzel, Lise
Liposits, Gabor
Johansen, Julia Sidenius
Detlefsen, Sönke
Egendal, Ida
Shim, Susy
Christensen, Signe
Pfeiffer, Per
Ladekarl, Morten
Article History
Received: 19 May 2023
Accepted: 31 May 2023
First Online: 16 June 2023
Declarations
:
: 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 [CitationRef removed]. All patient data will be handled in accordance with the Danish data protection laws (“Databeskyttelsesreglerne, loven og -forordningen”) and the Danish adaptation of the European Union General Data Protection Regulation (GDPR). The biomarker studies will be finalized when the clinical trial has concluded and will have no impact on the treatment of patients in the trial. No new research examinations of biological samples will be carried out without the permission of the Danish Ethics Committee.
: The study results will be uploaded to EudraCT as soon as possible and no later than 1 year after the end of the study. Data will then be published on clinicaltrialsregister.eu. Results from the study will also be published in international peer-reviewed journals/meetings independently of study outcome. Authorship will be attributed according to the International committee of medical journal editors (ICMJE) guidelines [CitationRef removed].
: I.M.C. reports institutional research grants from AstraZeneca, Roche, Bristol Myers Squibb, Celgene, Genis, and Varian Medical Systems; advisory board fees from Amgen and AstraZeneca; and travel and accommodation expenses from Roche, Bristol Myers Squibb, Celgene, and Bayer. M.L. received an unrestricted research grant from Scandion Oncology A/S, Denmark. All other authors reported no competing interests.