The Simmons Cancer Center Biomarker Research Core (BRC) supports the design, implementation, and oversight of biomarker/correlative studies for investigator-initiated cancer clinical trials including the following: study design and planning, specimen collection and processing, and coordination with other campus core facilities.
- Coordinate with Laboratory Correlates Working Group (LCWG) to enable and enhance scientific analyses of biospecimens associated with SCCC Phase 1-3 clinical trials.
- Provide standard operating procedures (SOPs) for handling and sample preparation of clinical trial biospecimens for development and completion of novel, mechanism-based interrogation.
- Enable integration of pharmacokinetics, pharmacodynamics, and patient responses.
- Provide logistics for reimbursement of laboratories performing correlative analyses.
- Consultation Services
Serving as an advisory body to the Biomarker Research Core (BRC), the Laboratory Correlates Working Group (LCWG) meets on a monthly basis. Individuals potentially interested in receiving BRC assistance with planning, performance, and analysis of correlative studies may contact BRC Manager, Farjana Fattah, Ph.D., M.B.A.
Potential BRC users may be invited to present their concept at an LCWG meeting, during which relevant experts will offer initial guidance, including cost estimates. Details of the plan and budget will be discussed with the investigator. The costs for further consultations, if necessary, will be included in the budget estimates either as hourly charges, personnel percent effort, and/or other format depending on sponsor requirements.
Assistance with grant preparation, potentially including generation of preliminary data, may also be provided. Further guidance may include critical aspects of experimental design, regulatory considerations, data acquisition and analysis, and preparation of proposals, protocols, and manuscripts.
- Clinical Trial Logistic Support Services
- Work with trial investigators to identify relevant laboratory correlates
- Assist in writing laboratory correlative sections for letters of intent (LOIs) and protocols
- Develop budgets for correlative studies
- Provide pilot funding for development and validation of novel biomarker analyses
- Develop methods and perform analysis of specimens
- Enable reimbursements for laboratories engaged in analyses
- Data management and analysis
- Provide operational support for multi-center clinical trials
- Collect, log, and track samples; distribute samples to collaborating research laboratories/core facilities
- Coordinate histologic assessment of biopsies, facilitate routine processing of samples (serum, plasma, lymphocyte prep, etc.), and coordinate advanced processing of samples (flow-cytometry, immunohistochemistry, proteomics, protein expression, gene expression array analysis, etc.)
- Biospecimen Processing, Storage and Shipping Services
- Aliquot whole blood
- Routine blood processing (plasma, serum)
- Urine aliquots
- RNA isolation
- DNA isolation
- Cell-free DNA (cfDNA) plasma processing
- Enzyme-linked immunosorbent assay (ELISA)
- Real-Time qRT-PCR
- Lymphocyte separation or buffy coat collection
- Isolation of peripheral blood mononuclear cells (PBMCs), monocyte, nature killer cells (NK), lymphocyte (T cells and B cells), and granulocyte, etc.
- Isolation of bone marrow mononuclear cells (BMMCs)
- Cell isolation using magnetic beads
- Fluorescence in situ hybridization (FISH) assay
- Protein isolation laboratory analyses
- Flow cytometry processing/runs/analysis, cell sorting
- Mass flow cytometry staining/analysis
- Western blotting (up to 20 samples), including Western blot re-probing
- Immunohistochemistry (IHC)
- Unique assay development
- Other protein analyses
- Sample receiving, storage, and distribution
Note: Send SCCCBRC@utsouthwestern.edu to Biomarker Research Core to access the current rates for the services.
David E. Gerber, M.D., Co-Director
Professor of Internal Medicine (Hematology-Oncology) and O’Donnell School of Public Health
Jason Park, M.D. Ph.D., Co-Director
Professor of Pathology and McDermott Center for Human Growth and Development
Farjana Fattah, Ph.D. M.B.A., Manager
Assistant Professor of Simmons Comprehensive Cancer Center