# Biomarker, Bioinformatics and Biorepository Core

> **NIH NIH U19** · DUKE UNIVERSITY · 2022 · $51,843

## Abstract

PROJECT SUMMARY – Biomarker, Bioinformatics and Biorepository Core
The Duke/UT Southwestern Glioblastoma Therapeutics Network (GTN) team will complete pre-clinical
development of a novel treatment (6-thio-dG) for patients with glioblastoma (GBM) and investigate its biologic
activity in an early-phase clinical trial. This Biomarker, Bioinformatics and Biorepository Core (Bio-MIR Core) will
support this mission by 1) providing logistical, biomarker, biostatistical, bioinformatic and biorepository support
that enables this GTN team’s investigators to optimize 6-thio-dG treatment for patients with GBM, and 2) serving
as a resource to other GTN sites by enabling the broader network to access the same expertise and tissues.
The Bio-MIR Core will be indispensable for the successful conduct of the studies proposed in this application,
including the early-phase clinical trial of 6-thio-dG, by standardizing protocols for the collection of tissues and
centralizing analyses of key biomarkers of patient eligibility and tumor response to 6-thio-dG treatment (Aim 1).
We will provide expert neuropathologic consultation through central review of previously resected tumors and
ascertain IDH1/2 and TERT-promoter mutation status using CLIA-approved assays to determine eligibility to
receive 6-thio-dG. Following 6-thio-dG treatment and tumor resection, the Bio-MIR Core will again oversee
central neuropathologic review and measure pharmacodynamic endpoints, including γH2AX measures of DNA
damage (primary trial endpoint). The Bio-MIR Core will provide biobanking services for the collection, processing
and storage of all GBM patient tissues in a CAP-certified setting, and distribute these tissues both within the
Duke/UTSW GTN and across all GTN sites (Aim 2). The Bio-MIR Core will also provide biostatistics and
bioinformatics expertise for the conduct, analysis, and reporting of correlative studies, and ensure data integrity
through centralized integration of clinical data, including multi-platform data integration and coordination (Aim 3).
Further, the Bio-MIR Core will promote an exemplary research culture wherein best data management practices
are used throughout to ensure data integrity, provenance, security, and reproducibility of study findings. The Bio-
MIR Core will benefit from institutional and NIH investments made in key shared resources, including clinical
data warehousing and multi-institutional biobanking and specimen sharing, and utilize the expertise of
investigators that have conducted multi-center GBM research for more than three decades. The Bio-MIR Core
will facilitate collaboration between GTN investigators and will also work with the designated Network
Coordination Center for trans-GTN sharing of resources and participation in clinical trials of therapies advanced
by the GTN Steering Committee to multi-center evaluations. In this manner, the Bio-MIR Core will serve as an
indispensable resource helping to achieve the GTN’s overall goal of developing...

## Key facts

- **NIH application ID:** 10488239
- **Project number:** 5U19CA264385-02
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** ROGER E MCLENDON
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $51,843
- **Award type:** 5
- **Project period:** 2021-09-13 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10488239

## Citation

> US National Institutes of Health, RePORTER application 10488239, Biomarker, Bioinformatics and Biorepository Core (5U19CA264385-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10488239. Licensed CC0.

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