I. Clinical Protocol Personalized Medicine Based on Molecular Profiling of Pediatric and Young Adult Patients with Cancer

1.0 Introduction...................................................................................................5 2.0 Study Overview.............................................................................................5 3.0 Background...................................................................................................6 4.0 Objectives...................................................................................................13 5.0 Eligibility.....................................................................................................14 6.0 Subject Enrollment.......................................................................................14 7.0 Biospecimen Collection................................................................................18 8.0 Clinical Data collection.................................................................................21 9.0 Management and Allocation of Specimens and Data.........................................22 10.0 Research.....................................................................................................23 11.0 Statistics.....................................................................................................28 12.0 Benefits and Risks.......................................................................................28 13.0 Data and Safety Monitoring...........................................................................29 14.0 References..................................................................................................37 APPENDIX 1: Study Calendar APPENDIX 2: Sample Molecular Report APPENDIX 3: Adverse Event Reporting Form APPENDIX 4: Genes Queried APPENDIX 5: Genetic Information Nondiscrimination Act