Patient Accrual and IRB

Designation of ChristianaCare as the single IRB of record. The ChristianaCare IRB is responsible for evaluation and approval of all human subject research projects conducted collaboratively between Wistar and the HFGCCRI. The process includes Initial Review, Amendments, Continuing Review, Closure and Adverse Event reporting for all joint protocols. The assignment of a single IRB of record has rapidly accelerated the pace of protocol approval and facilitated the transfer of primary tumor samples from the HFGCCRI Tissue Procurement Center to collaborating Wistar Cancer Center members.

The Cawley Center For Translational Cancer Research is a 7,000-sq.ft. wet laboratory space housed in the HFGCCRI. The Cawley Center currently houses instrumentation for evaluation of patient blood samples, the Gene Editing Institute and research laboratories. To meet the needs of our research teams the Gene Editing Institute has been integrated with the Wistar Shared Resources, providing Wistar investigators with access to expertise and advanced technology for gene editing (CRISPR/Cas9) projects.

The Tissue Procurement Center (TPC) currently houses over 5,000 catalogued cancer tissue, normal tissue and blood samples. All specimens from the TPC are under IRB-approved protocols and patient consent. Sample accrual is enabled by the joint Wistar-HFGCCRI Institutional Review Board. Protocols are created for collection of fresh biospecimens, including fine-needle aspirate, biopsies, surgical resections, and biological fluids from cancer patients. HFGCCRI staff perform patient consent, sample collection and delivery for Wistar investigators with approved IRB protocols. Pilot projects allowing up to 10 samples for proof-of-concept are also available. Standard operating procedures for courier-based delivery of primary tumor samples from the HFGCCRI to Wistar have been put in place to ensure full regulatory compliance for transfer of biohazard material across state lines. Furthermore, a Biomedical Research Support Shared Resource was developed at Wistar to facilitate Wistar-HFGCCRI collaborations by managing resources for clinical studies including the CDETweb® system for sample and data management. Fresh tumor samples arrive at Wistar in approximately one hour from collection and are available five days a week.

The Clinical Trials Program provides an opportunity for community physician engagement and increases participation of minority and underserved communities in oncology clinical trials across the state of Delaware. Through the support of the NCI Community Oncology Research Program (NCORP), the HFGCCRI is one of the largest community-based cancer programs in the U.S. with over 100 active clinical trials in treatment, prevention and disease control. In addition, a robust pharmaceutical clinical trial program conducts phase I, II and III protocols that do not compete for patient accrual with the NCORP trials. A Clinical Protocol and Data Management office provides centralized, real-time management of all oncology clinical trials at the HFGCCRI, including patient coordination, secure repository of protocol-specific data, patient safety, and regulatory reporting.

A Statewide High-risk Family Cancer Registry was established in 2002 and is the first and only statewide program of its kind in Delaware. The program is staffed by seven full-time genetic counselors based at the HFGCCRI who travel to the Tunnel Cancer Center at Beebe Hospital and Nanticoke Hospital in Sussex County, so patients can undergo genetic counseling and gene testing at their own cancer centers and hospitals. Pawel Pomianowski, M.D., director of Medical Genetics and Genomics, oversees this program.

The HFGCC Community Outreach Program offers education and screening opportunities for early detection of skin, prostate, breast, cervical, lung, and colorectal cancers as well as combination screening for cardiovascular, diabetes and other cancer risks statewide. The Outreach Program has been instrumental to the success of the state-sponsored colorectal screening initiative and lung cancer screening.