Schöttker, Ben
Chen, Li-Ju
Caspari, Reiner
Brenner, Hermann
Funding for this research was provided by:
Deutsches Krebsforschungszentrum (DKFZ)
Article History
Received: 15 February 2023
Accepted: 5 April 2023
First Online: 18 April 2023
Declarations
:
: Ethical approval for the study was granted by the responsible Ethics Committee of the Medical Faculty, Heidelberg University at February 8th, 2023. If needed, protocol amendments will be issued to this ethics committee before implementing them. The study will be conducted in adherence with the “Ethical principles for medical research involving human subjects” of the 18th World Medical Association General Assembly in Helsinki (1964) in their current version. All data obtained in the course of the study will be treated pursuant to the Federal Data Protection Law (Bundesdatenschutzgesetz) and the European ordinance (EU) 2016/679 (Datenschutz-Grundverordnung). The trial was registered in the German Clinical Trials Register “DRKS” before the first patient was recruited. All participants provide written informed consent before enrolment in the OPTIMAL trial. Patient participation in the study is voluntary. The informed consent to participate in the study may be withdrawn by the patient at any time without disadvantages for further medical care.
: The authors declare no competing interests.
: Not applicable.