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

Melanoma Clinical Trial

Official title: Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To perform standardized molecular analysis for patients at MD Anderson to assist in personalized cancer therapy.

II. To determine the frequency of mutations and co-mutations and other alterations in cancer-related genes in different tumor types.

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 ribonucleic acid (RNA) and protein expression, and plan additional pathway-targeted therapy trials.

II. To determine how somatic and germline mutations in cancer-related genes, other molecular alterations affect response to commonly used anti-tumor therapies and cancer outcomes.

III. To determine genomic alterations detectable in plasma and their evolution with treatment.

IV. To perform multiplex and non-multiplex protein and protein/RNA screening using different platforms such as immunohistochemistry (IHC), immunofluorescence, (IF) mass spectrometry (MS), and nanostring of slides or tissue microarrays.

V. To determine feasibility of identifying actionable targets and rationale drug combinations based on gene expression profiling and systems biology.

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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT01772771
• Study type: Observational
• Source: M.D. Anderson Cancer Center
• Contact: Funda Meric-Bernstam, MD
• Phone: 713-792-6940
• Email: fmeric@mdanderson.org
• Status: Recruiting
• Start date: March 1, 2012
• Completion date: March 1, 2033