The Biospecimen Services Shared Resource (BSSR) is CAP Accredited.
OSUCCC Clinical Research Operations Director: Nancy Single, PhD
Key program objectives
The Specific Aims of the BSSR are to:
- Aim 1: Collect data and specimens from OSUCCC – James patients using the IRB-approved Total Cancer Care (TCC) universal consenting and biobanking protocol for future unspecified research.
- Aim 2: Prospectively procure biospecimens for specific IRB-approved protocols.
- Aim 3: Provide high-quality, centralized biorepository services in a CAP-accredited biorepository.
The BSSR is comprised of three arms:
Arm 1: Total Cancer Care (TCC)
TCC PI: Daniel Stover, MDTCC Operations Director: Laura Monovich, MBA
The first arm is a universal consenting and biobanking protocol, Total Cancer Care (TCC). Total Cancer Care® allows for the collection of blood and remnant tissue from surgical procedures. Eligibility includes patients 18 years of age and older, with and without cancer, who are seen at the OSUCCC – James. Participating patients also consent to the use of their medical and genomic information. This lifetime consent allows for recontacting patients for an annual health status update, if needed, and/or to notify them about opportunities to participate in clinical trials for which they are eligible. As of January 2025, over 70,700 patients at the OSUCCC – James have consented to participate.
Plasma, serum and DNA, along with fresh frozen tissue, are stored for future research. The collected biospecimens are stored at the College of American Pathologists (CAP)-accredited BSSR biorepository located at The Ohio State University's Polaris Innovation Center. Researchers may receive specimens and data with subject identifiers with IRB-approval, or de-identified and coded-limited data sets without additional prior IRB approvals.
TCC is the single protocol used by the Oncology Research Information Exchange Network (ORIEN), which was formed in 2014 through a partnership between the OSUCCC – James and Moffitt Cancer Center in Tampa, Florida, as a collaboration to accelerate cancer research discoveries that can translate to more effective clinical care. Using TCC, ORIEN has created a collaborative, “rapid-learning” environment that will share de-identified patient data to hasten the development of targeted treatments and more quickly match eligible patients to clinical trials. The network currently includes 18 cancer centers.
Arm 2: Prospective Procurement
Program Manager: Scott Scrape, MD
The second arm of the BSSR provides prospectively procured tissue from surgical procedures to OSUCCC – James investigators who require pathology specimens that have not been previously banked. The Department of Pathology Tissue Procurement Service (TPS) operates within The Ohio State University Wexner Medical Center (OSUWMC) hospitals to facilitate research requiring the procurement of human tissues. All human tissue specimens taken for research at OSUWMC hospitals must be coordinated through TPS. Specimens are processed according to protocol.
Arm 3: BSSR Biorepository
BSSR Biorepository Manager: Jason Bacher, BA
Arm 3 of the BSSR provides high-quality, centralized biorepository services in a College of American Pathologists (CAP)-accredited BSSR biorepository. Specimen processing techniques include but are not limited to serum and plasma, DNA extraction from peripheral blood, frozen tissue, saliva, buccal swabs and immortalized lymphoblast or fibroblast cell lines. Specimens are maintained in locked freezers in a secure building that can only be accessed by employee keycards. All information pertaining to the sample processing and storage as well as related clinical information is maintained in a secure web-based database. Each sample receives a unique identifier. Information such as sample type, date sample was collected, sample concentration and storage location is entered into the biorepository’s database.
The biorepository is monitored by the Rees Scientific Environmental monitoring system to ensure proper environmental and storage conditions 24 hours a day. In the event of a power failure, the biorepository is connected to a diesel-powered generator that will keep the freezers operating until full power is restored. To date, the BSSR biorepository has banked over 350,000 specimens and distributed 50,00 specimens.
Cross-institutional work
The Oncology Research Information Exchange Network (ORIEN) is a unique alliance to integrate “big data” and data sharing for cancer research and care. As mentioned, ORIEN was founded by the OSUCCC – James and Moffitt Cancer Center and now includes 18 members. The foundation of the alliance is the common Total Cancer Care® (TCC) protocol, a longitudinal surveillance study of cancer patients that allows for lifetime consent, access to clinical outcomes data, genomic sequencing of tumors and the ability to recontact the patient.
Member institutions agree to three basic principles in the protocol and consent: 1) Follow the patient throughout their lifetime permitting sharing of data and information; 2) Study the patient’s tumor using molecular technology; and 3) Maintain contact with the patient.
As of January 2025, over 386,000 patients have consented to participate in TCC across the ORIEN network. The ORIEN Avatar Research Program was launched in 2016, which generates prospective molecular (NGS) data on patients that is linked to longitudinal clinical data. To date, over 30,400 patients are in the Avatar program across ORIEN, with over 5,000 of those from the OSUWMC.
Contact BSSR
Arm 1 – TCCP
For questions and protocol coordination:
Nancy Single, PhD
OSUCCC Clinical Research Operations Director
Nancy.Single@osumc.edu
For specimen and data access:
Laura Monovich, MBA
Laura.Monovich@osumc.edu
Arm 2 – Prospectively Procured Biospecimen Specimens
Scott Scrape, MD
Scott.Scrape@osumc.edu
Arm 3 – BSSR Biorepository
Jason Bacher, BA
Jason.Bacher@osumc.edu
This Shared Resource is supported by the Cancer Center Support Grant (P30CA016058).