Ethic considerations and dissemination
toxicity, tumor, Tumour
TUMOR, TUMOUR, POSITIVE
The study is conducted according to the international standards of ICH/Good Clinical Practice, 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 (H-19089780; date of approval: 19-JUN-2020), the Danish Data Protection Agency (P-2020-210; 03-MAR-2020) and the Danish Medicines Agency (EudraCT 2019–004771-40; 17-FEB-2020).All patients are informed about genetic findings revealed by genomic analysis and their potential consequences. In case of incidental findings with potential serious consequences for either the patient or the patient’s family, the patient will be offered referral for genetic counseling. Furthermore, the patients are informed that personal study-related data will be used by the Sponsor in accordance with the General Data Protection Regulation, the Data Protection Act and the Health Act. All patients are assigned a unique study ID to maintain patient confidentiality, if/when data is pooled with data from collaborating studies. In accordance with Danish law, research subjects are covered by Danish health care liability insurance.Protocol amendments and modifications will be submitted for approval to the competent authorities and all relevant collaborators (e.g., sites, pharmacies, monitors, and funders) will be informed by the trial coordinating team. Results will be published in international and peer-reviewed scientific journals and presented at international conferences. Positive, negative as well as inconclusive results will be published. Designation of authorships will be based on the criteria of the Vancouver Convention (ICMJE).Upon the completion of a cohort, individual and/or pooled cohort results will be published. General study results (such as overall submission, accrual, toxicity and efficacy analyses, as well as concordance between historic and pre-treatment genomic tumor profiles) will be published when appropriate. Individual case reports will only be published if clinically relevant. Publications will be prepared according to the Reporting Recommendations for Tumour Marker Prognostic Studies (REMARK [