Document is current

Article History

Received: 14 April 2022

Accepted: 24 May 2022

First Online: 13 June 2022

Declarations

:

: The study will be conducted according to the principles of the declaration of Helsinki (Fortaleza, Brazil, October 2013), in accordance with the Medical Research Involving Human Subjects Act and in accordance with Good Clinical Practice standards. The study protocol has been approved by the ethics committee of all patient recruiting centers: the ethics committee of University Clinical Hospital of Valencia, Spain (reference number 2018/205), the institutional review board of VU University Medical Center Amsterdam (reference number 2019.355. NL 69480.02919), the ethics committee of Instituto de Previsión Social, Asuncion-Paraguay (reference number CA N°11-020/19), the ethical research committee of Instituto Alexander Fleming, Buenos Aires Argentina (Resolution July 25th, 2019, for LEGACy study 1 and 2 and October 3rd, 2019 for LEGACy study 3); the ethical committee of Instituto Nacional de Cancerologia (INCAN, México (reference number INCAN/CEI/0486/19). The ethics committee of the University Center of Sao Joao and Medicine Faculty of Porto University, Portugal, reference 100/019, the scientific ethical Committee Pontificia University of Chili, reference 180806007, and the Drug research ethics committee of Vall d’Hebron University Hospital, Barcelona, Spain with references PR (AG)387/2019 approved on October 29th, 2019 for LEGACy study 1, PR (AG)388/2019 approved in December 13th 2019 for LEGACy study 2 and PR (AG)419/2019 approved in January 30th, 2020 for Legacy study 3 respectively. In case of important protocol modifications, the Principal Coordinating Investigator will inform the Principal Investigators of all study sites. They will then forward the amendments to the associated ethics committees and trial participants. All participants provide written informed consent before study enrolment. Each data-contributing partner shall undergo online ethical and data training before the start of data collection and will manage access to the data of their center through this security system. Inside this system, a patient ID generator will generate a unique code for each participating patient to maintain data privacy.

: Not applicable.

: The authors declare that they have no competing interests.