Document is current

Article History

Received: 1 June 2022

Accepted: 1 July 2022

First Online: 19 July 2022

Declarations

:

: The protocol, CHOP and COH informed consent forms, recruitment materials, and other requested documents have been reviewed and approved by the Children’s Hospital of Philadelphia Institutional Review Board with respect to scientific content and compliance with applicable research and human subjects’ regulations {24}. The study protocol has undergone full external peer review by the National Health Institute/National Cancer Institute (NIH/NCI) as part of the peer review process. Subsequent to initial review and approval, Children’s Hospital of Philadelphia Institutional Review Boards will review the protocol at least annually. Any modifications to the protocol or the informed consent form that may include but are not limited to the procedure of the study, the study design, the conduct of the study, and the changes to the study staff members, will be made through a formal amendment submitted through and approved by the site IRB {25}. The written informed consent will be obtained from a parent or guardian for participants under 18 years old. The written informed consent will be obtained from the participants who are 18 years old or older. The protocol is the 4^th edition and was last updated in February 22^nd, 2022 {3}.

: Not applicable as study enrollment has not commenced.

: There is no competing interest to declare on the part of any named author {28}.