Biospecimen Repository Service - Services
Anonymized Biospecimen Repository: This service provides tissue for research discovery, procedure optimization, and correlations not requiring patient outcome information. Specimens are acquired as tissue discards once clinical diagnostic and prognostic needs are met. Limited annotation from the pathology report includes gender, age, tissue type, and pathologic/histologic diagnosis. As links to identifiers are broken upon banking, no additional information is available to investigators on these specimens. There are currently over 10,900 specimens representing over 50 different tissue types (normal and/or tumor tissue) including breast, bowel, upper GI, GU, lung, melanoma, sarcoma, prostate, kidney, lymphoma, gynecologic, and other assorted tissue in the BRS. Through this collaborative work we have supplied anonymized archival tissues to aid in the creation of more than forty Tissue Microarrays (TMA), by the Histopathology and Imaging Shared Resource including breast, thyroid, multiple organs/tissues, and ovary.
Clinical Trial Support: This service encompasses specimen procurement, processing, storage, distribution and shipping. When biospecimens are required, the Office of Human Research Services (OHRS) notifies BRS, through a secure, web-based account, of study participants undergoing procedures for specific protocols, the date, time, and location of that procedure, and specimens to be retrieved. BRS, on collection of the specified specimens, verifies specimens to protocol patient and de-identifies the specimen through the OnCore® BioSpecimen Module. Specimens are collected, appropriately processed (including paraffin and/or OCT embedding, separation of PBMCs, serum, etc.) and stored. They are then provided to investigators for study. In the case of cooperative group trials, specimens are appropriately preserved and shipped to receiving laboratories. These procedures allow the BRS to also collect specimens that are required to be provided to investigators rapidly in fresh condition.
Clinically-annotated Biospecimens: BRS has recently expanded its role to include clinically-annotated specimens. BRS is now able to prospectively consent patients to allow the acquisition and distribution of de-identified specimens along with longitudinal information. Consent is obtained from subjects at RWJUH and in the CINJ ambulatory care facility. Biospecimens and clinical information have all identifying information removed prior to distribution to investigators. BRS maintains a protected link between biospecimen and clinical information identifiers and may only be accessed by designated BRS personnel. Thus, the BRS acts as the “Honest-Broker” for the distribution of these clinically-annotated banked biospecimens. This repository was developed in response to the needs of researchers for clinically-annotated biospecimens not obtained as part of a therapeutic trial. A program for the collection and annotation of specimens from breast cancer patients and healthy individuals has been piloted within this grant cycle through an IRB-approved protocol that has, to date, accrued over 1800 subjects from whom whole blood, genomic DNA, and clinical annotations are available.
DNA Repository: As an adjunct to the annotated repository above, the BRS has created a DNA Repository. The BRS, as well as CINJ physicians, consent patients for submission of biospecimens in the bank. The BRS coordinates the recruitment and consent of patients, procures samples, accession and tracks participants. BRS also processes, ships and tracks biospecimens using the OnCore® database and barcoding features. Whole blood specimens are processed into DNA by the Rutgers University Cell and DNA Repository (RUCDR).
Expert Consultation and Clinical Protocol Support: The Biospecimen Repository Service resource directors and/or resource manager meet with CINJ members to consult on planned clinical, translational, and basic research studies that require tissue for scientific correlations. This is to assure the feasibility of proposed studies based on biospecimen needs and to ensure that the procedures are detailed in the clinical protocols. It also assures that investigators know what technologies are available for obtaining and processing biospecimens so investigators can propose studies that incorporate the use of biospecimens whenever appropriate. Assistance and consultation is also provided to basic researchers to navigate the regulatory requirements of clinical and translational research. The BRS assists with the application process to the SRB (PRMS) and IRB, and troubleshoots potential barriers to the safe and ethical acquisition of human specimens. A BRS representative attends the weekly meetings of the OHRS to assure close collaboration.