Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program

PRIMARY OBJECTIVES: I. To perform molecular analysis for patients at MD Anderson to assist in personalized cancer therapy. II. To determine the frequency of mutations, co-mutations and, other alterations including germline polymorphism and deleterious mutations (germline genetic factors), in cancer-related genes within different tumor types, and to determine patient preference for return of results. III. To establish a database of somatic mutations, copy number alterations, gene fusion/translocation information and other biomarker alterations and clinical characteristics that can be used to select patients that may be eligible for new targeted therapy trials. SECONDARY OBJECTIVES: I. To determine enrollment to pathway-targeted therapy trials by cancer genotype and RNA and protein expression and plan additional pathway-targeted therapy trials. II. To determine how somatic and/or germline mutations (including polymorphisms) in cancer-related genes, and other molecular alterations affect response to anti-tumor therapies and cancer outcomes and to determine how germline polymorphisms affect toxicity and side effects with cancer therapy. III. To determine genomic alterations and other biomarkers detectable in plasma, exosomes or blood and their predictive value and evolution with treatment. IV. To perform protein and RNA screening using different platforms such as immunohistochemistry (IHC), multiplex IHC, immunofluorescence (IF), mass spectrometry (MS), and Nanostring including assays from slides or tissue microarrays and image analysis strategies including digital pathology. V. To determine feasibility of identifying actionable targets and rationale drug combinations based on gene expression profiling and systems biology. VI. To determine feasibility of identifying novel antigens and other targets for novel strategies such as vaccines, immunotherapy and cell surface therapy. VII. To use integrated biomarker and clinical data in conjunction with novel computational tools including large language models, machine learning, and other artificial intelligence tools for biomarker discovery and therapy-matching. OUTLINE: Patients' previously collected tissue samples are analyzed. Patients may also undergo collection of blood, saliva or buccal samples for analysis. Patients' medical records are reviewed.