The Solid Tumor Translational Science Shared Resource (STTSSR) assists OSUCCC – James clinical investigators in designing and managing correlative studies for the identification or validation of biomarkers as part of phase I and II trials.
STTSSR experts provide both assay development and data analysis, and they work with the OSUCCC – James Clinical Trials Processing Laboratory Shared Resource to provide seamless coordination of assays during clinical trials.
In addition, the STTSSR:
- Serves as a central laboratory for the acquisition and processing of clinical-trial specimens, a particularly valuable service for clinician investigators who want to perform correlative studies but lack laboratory space;
- Helps develop strategic partnerships between OSUCCC – James investigators and pharmaceutical and biomedical companies that are conducting clinical trials at Ohio State that require correlative laboratory studies;
- Works closely with the OSU Pathology Core Facility to ensure that assays required for patient selection and stratification, to determine treatment, are performed under Clinical Laboratory Improvement Amendments (CLIA) standards.
A liquid-biopsy assay developed by the STTSSR for a recent OSUCCC – James clinical trial (OSU-12064) offers an example of the translational research services provided by the STTSSR. The randomized phase II trial involved patients with advanced or metastatic iodine-refractory thyroid cancer with mutated BRAF or BRAF gene fusion.
The STTSSR designed a correlative study for this trial that used a liquid-biopsy technique to evaluate whether levels of BRAF mutations in circulating tumor-cell DNA from patient samples collected at baseline and throughout treatment could predict response to treatment and tumor progression.
The STTSSR plans to use this liquid-biopsy capability in future translational research studies. Other laboratory services provided by the STTSSR include:
- Purifying circulating miRNA from plasma, urine and saliva;
- Purifying RNA, miRNA and protein from cells, blood or fresh frozen samples;
- Custom-designed targeted sequencing panels;
- Allele-specific PCR;
- Identifying signaling pathways using immunohistochemistry and immunoflourescence;
- Luminex multiplex protein assays.