UNITS: The UNC / UT National Clinical Trials Network Group Integrated Translational Science Production and Consultation Center

PROJECT SUMMARY/ABSTRACT In the current era of Precision Medicine, molecular studies are an integral component of cancer clinical trials. Amongst the most powerful techniques connecting targeted therapies to specific patients are assays that interrogate nucleic acids (DNAseq and/or RNAseq), which are now most typically done using massively parallel sequencing (MPS). RNAseq offers an extremely powerful approach for querying the tumor genome, and gene expression profiles have proven value in providing predictive information, prognostic information, and also critical information on the tumor microenvironment. In addition, DNA based approaches can also be clinically informative in detecting somatic small sequence alterations (single nucleotide variants (SNVs), insertions, and deletions) as well as larger structural variations including gene rearrangements, loss of normal DNA sequences, or sequence gains (amplifications). Alternatively, sequencing assays can target DNA from noncancerous cells to address additional questions including identification of familial predisposition, and genotyping of drug metabolizing enzymes of therapeutic importance. Through continuation of this Project, the UNG / UTHSC UNITS team will provide high volume sequencing in a regulatory compliant manner from day one of the extension. As a world leader in the production of human RNA-based cancer data, from both frozen and FFPE, including RNA sequencing and targeted RNA quantification, RNA-based assays are offered within a compliant setting. We are also highly experienced with common, and complex, DNA-based assays and offer these as well. Aims 1 and 2 of this proposal involve providing a compliant mechanism for high sample throughput for RNA- and DNA-sequencing from samples provided from multi-institutional cooperative group trials. RNA sequencing will utilize total RNA sequencing to provide comprehensive coverage. DNA sequencing will be offered for both whole exome and targeted capture by MPS. The third aim is to develop and provide data sharing formats and an infrastructure for the proper dissemination of clinical trial sequence-based patient information, which is needed is this era of Big Data.