Real-time central review: A report of the first 3,000 patients enrolled on the Children’s Oncology Group Renal Tumor Biology and Risk Stratification protocol AREN03B2.

10000 Background: The Children’s Oncology Group (COG) Renal Tumor (RT) Biology and Risk Stratification Protocol incorporates real-time central review to direct risk stratification and enrollment on COG therapeutic studies. We assessed the feasibility of the real-time central review process and its impact on the accuracy of risk stratification. Methods: 3,000 patients were enrolled on AREN03B2 between 2/2006 and 1/2012, with submissions from 214 COG institutions. Eligible diagnoses included any RT and extra-renal Wilms tumor or non-CNS rhabdoid tumor. Enrollment on AREN03B2 was required to enroll on a RT treatment study. Submission of pathology slides, radiology images, operative reports, and tumor and blood for analysis was required within 7 days of surgery to meet enrollment deadlines stipulated by the therapeutic studies. Central pathology review for histology and stage, radiology review for presence of bilateral lesions and pulmonary metastases, and surgical review for operative stage were completed el...