ALTE11C2: Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazonane and Prevention of Anthracycline-related Cardiomyopathy
ALTE11C2_Dexraz
What is the goal of the study?
PedCIRB intent to open. Per Amendment 3, Stratum 3 is for participants with osteosarcoma. There might be osteosarcoma patients treated at SCH that might be eligible for this study now. Note to File: This study is different from the usual PedCIRB intent to open notifications we see at SC. Seattle Children's participation is only limited to the the secondary aims of the study per protocol Amendment #2, and it only involves the updating of event and vital statuses of participants who initially enrolled at another participating ALTE11C2 institution, but that have now migrated to SCH. PedCIRB has approved Seattle Children's (and other institutions in a similar situation) to be involved in this limited participation and have granted a full waiver of informed consent. Therefore, the study team is also requesting a full waiver of HIPAA authorization to cover recruitment and also the conduct of the study, since there will never be any contact with the participant. They will only retrospectively be accessing medical records, and providing the status information to PedCIRB. Discussed during TSL with LB. Study team have addressed the waiver criteria, and a waiver of authorization has been granted.
Who can participate in the study?
Please contact the study team listed below to learn more.