Clinical Biomarkers Core

Facilities

Located on the CNRM Twinbrook Campus, CNRM Twinbrook Building, 12725 Twinbrook Pkwy, Rockville, Maryland

Biospecimen Repository

A Biospecimen Repository (BR) has been established to house biosamples and associated clinical and other data from participating study sites investigating TBI. Samples will be in the form of frozen human biological specimens. Data will be stored in electronic form and will consist of de-identified clinical history, neuroimaging findings, and laboratory data. Current protocols permit the holding in the BR of whole blood, plasma, serum and white blood cells obtained from TBI subjects and appropriate control subjects. Approval for additional types of biospecimens may be obtained in the future.

Purpose

It is hoped that the stored biospecimens and associated clinical data will assist in the development of a much needed new taxonomy for TBI that will aid in improving research inclusion criteria, provide better prediction of clinical outcomes, and contribute to the development of relevant monitoring of outcomes following therapeutic interventions in TBI.

Facilties and Management

CNRM BR samples will be stored at the CNRM Twinbrook facility in Rockville, Maryland. Samples will be collected from participating CNRM sites - this may include Military Treatment Facilities and civilian institutions such as the National Institutes of Health (NIH) and local hospitals. A Repository Manager is responsible for maintaining the storage facility under the oversight of a BR Steering Committee. Access policy will be determined by the Steering Committee. Samples will only be released for studies conducted under protocols subject to USUHS Institutional Review Board (IRB) review and approval.

Consent

Study investigators in all participating studies must have subjects consent to having their samples collected for this repository and stored as de-identified samples for up to 20 years.

Data Management

The CNRM Informatics Core is ultimately responsible for all data collected under this protocol. The USU IRB retains primary oversight responsibility for samples and de-identified data in the Repository. Enrolling site IRBs will retain primary responsibility for patient consent, clinical interaction with patients, protection of patients and their data while it is identified, any communication with patients including processing of requests for withdrawal from the program, and data quality.

Biomarker Assays in Development

A panel of multiplex assays for about 10 previously identified putative biomarkers for TBI is being developed. It is planned to subject all plasma samples submitted to the BR to this panel of assays. Selected panels of BR specimens will also be assayed for other putative biomarkers under specific CNRM protocols. Candidate biomarkers for which assays are in development will initially include:

  • BDNF
  • GFAP
  • ICAM-5
  • NSE
  • MCP-1

Candidate biomarkers for which assays may be added later include:

  • S100beta
  • Abeta
  • tau phospho-tau
  • IL-6
  • VEGF

Points of contact for information on core resources, policies, and procedures

  • Dr. Brian Cox, Biomarkers Program Leader, Email

Access to the use of these cores is subject to CNRM review and chargeback fees may apply.