NCT01772771

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12,000 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study performs standardized testing of tumor tissue samples to learn which genes are mutated (have changed) in order to provide personalized cancer therapy options to cancer patients at MD Anderson. This may help doctors use testing information on tumors to identify clinical trials that may be most relevant to patients. Researchers may also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes.

Detailed description

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.

Conditions

• Glioma
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Melanoma
• Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood, saliva/buccal swab samples
OTHER	Genetic Testing	Correlative studies
OTHER	Medical Chart Review	Review of medical records

Timeline

• Start date: 2012-03-01
• Primary completion: 2032-03-01
• Completion: 2033-03-01
• First posted: 2013-01-21
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States