BSSR Director: Heather Hampel, MS, LGC
OSUCCC Clinical Research Operations Director: Nancy Single, PhD
The broad mission of the OSUCCC Biospecimen Services Shared Resource (BSSR) is to support cutting edge translational research to advance the prevention, diagnosis and treatment of cancer. The BSSR is comprised of three arms as described below.
Arm 1: Total Cancer Care (TCC)
PI: Heather Hampel, MS, LGC
TCC Operations Director: Laura Monovich, MBA
TCC Consent Director: Cecilia DeGraffinreid, MHS
The first arm is a universal consenting and biobanking protocol, Total Cancer Care (TCC). Total Cancer Care® allows for the collection of blood in conjunction with clinically indicated blood draws and remnant tissue from surgical procedures. Eligibility includes patients 18 years of age and older, with and without cancer, who are seen at The 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.
Plasma, serum and DNA, along with snap frozen tissue, are stored for future research. The collected biospecimens are stored at the College of American Pathologists-accredited BSSR Biorepository located at The Ohio State University's Polaris Innovation Centre. Researchers may receive samples and data with subject identifiers with prior 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 through a partnership between the OSUCCC – James and Moffitt Cancer Center in Tampa, Fla., as a collaboration to accelerate cancer research discoveries that can translate to more effective clinical care. Using TCC, ORIEN will create 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 19 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 investigators who are in need of pathology samples that have not been previously banked. The Department of Pathology Tissue Procurement Service (TPS) operates within the OSUWMC hospitals to facilitate research requiring the procurement of human tissues. All human tissue samples taken for research at OSUWMC hospitals must be coordinated through TPS. Samples are processed according to protocol.
Arm 3: BSSR Biorepository
BSSR Biorepository Manager: Jason Bacher, BA
Arm 3 of the BSSR provides biospecimen processing and banking services to investigators for IRB-approved and grant-funded projects, including but not limited to SPOREs, P01s, R01s and statewide Pelotonia-funded initiatives. 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 that are 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 collected, sample concentration, and storage location is entered into the 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 140,000 specimens.
The Oncology Research Information Exchange Network (ORIEN) is a unique alliance to integrate “big data” and data sharing for cancer research and care. ORIEN was founded by The Ohio State University Comprehensive Cancer Center and Moffitt Cancer Center in May 2014 and now includes 19 members. The foundation of the alliance is the common Total Cancer Care® (TCC) protocol, a longitudinal surveillance study of cancer patients, which 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 August 2019, over 260,000 patients have consented to participate in TCC. The ORIEN Avatar Research Program was launched in 2016, which generates prospective molecular (NGS) data on patients which is linked to longitudinal clinical data. To date, over 14,000 patients are in the Avatar program. The Ohio State University Comprehensive Cancer Center – The James has enrolled over 53,500 patients in TCC and provided over 3,700 patient cases toward the Avatar program.