The Clinical Support Laboratory processes and works with samples from clinical trials at the National Cancer Institute and tests samples, with an emphasis on the immune system’s function. We work with principal investigators to study the status of the immune system in clinical trial participants or nonhuman primates who get treated with anticancer therapies designed to stimulate or affect their immune systems. 

Critical testing and support for clinical trials 

We provide custom services on immune-function testing and immunophenotyping support to principal investigators working on intramural clinical trials at the National Cancer Institute. Also, we are able to perform assessments for research. 

Our scientists supported a CD22 CAR T-cell trial and measured 15 markers of cytokine storm versus hallmarks of a related illness, hemophagocytic lymphohistiocytosis (HLH).  

We followed up on the HER-2 vaccine using the multicolor enzyme-linked immunospot (ELISPOT) assay, a very sensitive method used to detect low frequencies of antigen-reactive T cells to both IFN-g and granzyme B.   

High-quality biomarker tests and immunogenicity assays 

Our laboratory is known for high-quality biomarker tests, often performed in multiplex, as well as immunogenicity (anti-drug antibody) assays. We are CLIA-certified to perform a high-complexity assay. The group is currently assessing samples from patients on immuno-oncology therapies.

Collaboration Opportunities

The Clinical Support Laboratory has services available to researchers within the National Institutes of Health. Services can be requested through NAS or CREx. To inquire about publicly accessible services, contact the Frederick National Laboratory Partnership Development Office. 

NAS 

CREX 

Our sections and their expertise

Clinical Trials Processing Section 

The Clinical Trials Processing Section receives, processes, preserves, and records clinical trial samples. We are a front-end to the NCI Central Repository. In addition, on selected samples, principal invesitagtors may request that we perform specialized techniques for batch testing by other sections in the clinical support laboratory.

  • Separation of blood into component parts serum, plasma, PBMCs (also can receive other bodily fluids)

  • Isolation of DNA and RNA from some samples with commercially available kit technology 

Flow Cytometry & Cellular Immunology Section 

Our group analyzes expression of cell-surface markers and intracellular markers such as cytokines and transcription factors, providing flow cytometry services to investigators. We also analyze samples from simian immunodeficiency virus (SIV)–infected nonhuman primates.

We also develops cell-based immunology assays and provides immunological monitoring. We use developed and validated assays that evaluate innate and adaptive immunity.

 

  • Multi-color panels, up to 15 color, of both markers and ICS

  • Tetramer staining 

  • Measurement of intracellular kinase activity 

  • Cell-cycle analysis on clinical samples 

  • Cellular proliferation  

  • Antibody-dependent cell-mediated cytotoxicity (ADCC)  

  • NK cell–mediated cytotoxicity  

  • Singleplex and multiplex ELISPOT assays  

  • Live-cell metabolic assays 

Cytokine Testing Section 

The Cytokine Testing Section performs a range of assays for soluble biomarkers and provides Meso Scale Discovery and Luminex® assay platforms for testing, which increases sensitivity, shortens turnaround time, and decreases costs. They also now are offering performance of up to 100-plex on the Olink Signature Q100 proteomics platform.

  • Cytokines  

  • Chemokines  

  • Soluble receptors  

  • Other biomarkers 

Cell Culture Section 

The Cell Culture Section performs propagation of human cell lines and transfection. We prepare primary cultures from human punch biopsies to generate primary fibroblast cell lines. Intramural researchers at the National Cancer Institute or National Institutes of Health can request our services through NAS or CREx. 

  • Human B-cell immortalization using Epstein-Barr virus 

  • Establishment of primary fibroblast lines from skin biopsy 

  • Cell-line thaw and cell culturing to propagate into working cell banks