Signed study-specific informed consent Signed study-specific informed consent prior to registration Provision of informed consent prior to any study specific procedures Patients must provide study-specific informed consent prior to step 1 registration Patients must provide study-specific informed consent prior to registration The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration The patient or a legally authorized representative must provide study-specific informed consent prior to study registration