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

> **NIH NIH UG1** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $730,001

## Abstract

In the current era of Precision Medicine, laboratory studies are an integral component of cancer clinical trials.
Amongst the most powerful techniques connecting 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 now offers an extremely powerful approach for querying the tumor genome,
where gene expression profiles have proven value in providing prognostic information, predictive information,
and also critical information on the tumor microenvironment including quantitative measures of immune
infiltrations. In addition, DNA based approaches can also be clinically informative in detecting somatic
sequence alterations (mutations), structural variations (fusions), loss of normal DNA sequences (deletions), 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 this Project, the UNC / UTHSC UNITS team will provide high volume clinical grade sequencing in a
regulatory compliant manner from day one of the grant. 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 an FDA-
and CAP- compliant mechanism for high sample throughput for RNA- and DNA-sequencing from samples
provided from multi-institutional cooperative group trials. RNA sequencing will be offered in 3 formats, RNA-
Seq, NanoString, and Q-rt-PCR, to allow both comprehensive coverage and inexpensive targeted RNA
profiling. DNA sequencing will be offered for both whole exome and targeted capture by MPS, as well as
quantitative DNA measures by NanoString. 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.

## Key facts

- **NIH application ID:** 9892991
- **Project number:** 5UG1CA233333-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** David N Hayes
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $730,001
- **Award type:** 5
- **Project period:** 2019-03-13 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9892991

## Citation

> US National Institutes of Health, RePORTER application 9892991, UNITS: The UNC / UT National Clinical Trials Network Group Integrated Translational Science Production and Consultation Center (5UG1CA233333-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9892991. Licensed CC0.

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