Enhanced specimen tracking and Honest Broker System
A barcode system was implemented and specimen tracking is centralized through the OnCore® Biospecimen Module, allowing seamless integration of specimens with the clinical trial process and enabling clinical annotation of the specimens in a highly secure structure. In addition to automatic linkage to consented subjects in the OnCore® clinical trials management system, OnCore® supports de-identified specimen banking. In 2013, creation of a protocol (Rutgers Cancer Institute Protocol 001006; Rutgers IRB Pro20170000331 PI Javidian) that allows the Biorepository to bank specimens that can be linked with annotated clinical data found in the electronic medical record, clinical trial management system, tumor registry, and clinical data warehouse, greatly improved the ability of CINJ members to perform state-of-the-art translational research. The Biorepository interacts heavily with the Biomedical Informatics shared resource (Bioinformatics) to obtain data for research that is stored in the Clinical Data Warehouse. This includes all sequencing data as the core receives test results electronically from Foundation Medicine and the Comprehensive Genomics shared resource. Streamlined consenting, procurement, processing, banking, annotation, and delivery in one centralized service maximizes resources, ensures standardization, and promotes compliance. An honest broker system enables regular updating of clinical data that can be passed on to investigators without subject identifiers. David Foran, Director of Bioinformatics, runs the Data Governance Council (physicians, scientists, administrators, regulatory staff, and bioinformatics staff) to set policy and priorities and provide oversight for data warehousing and data-centric research projects.
Cancer Panels and Precision Medicine
The Biorepository is building panels that align with major research projects at Rutgers Cancer Institute of New Jersey. Many of the specimens in the panels are from patients recruited through the molecular tumor board, whose samples were sequenced with the Foundation One® cancer panel. The linkage of the specimens and the genetic data provides a valuable resource for clinical and translational research projects.
Biospecimens for Use in Research
The Biorepository provides biospecimens and histopathology services for basic research. Over the last five years, the distribution of specimens from the Biorepository has seen an 80% increase. Specimens distributed have gone from 619 in 2013 to 3,351 in 2017. The Biorepository has also supported grant submissions resulting in 11 R01’s and 16 federally funded grants by the NCI and DoD.
College of American Pathologists Certification
The Biorepository is prepared for CAP inspection and certification scheduled to take place April 2018. The certification applies to all three areas of the Biorepository. The process of preparing for this certification has been both challenging and enlightening, and it will lead to more comprehensive service, superior quality control and greater opportunities for research at Rutgers Cancer Institute of New Jersey.
Participation in ORIEN Consortium
An important benefit of participation in ORIEN (Oncology Research Information Exchange Network) projects is the increase in usage of our stored biospecimens for sequencing. Sequencing data from our biospecimens is readily available via the ORIEN data warehouse, as well as sequencing data from other centers who provide permission to share the data. We are currently participating in the ORIEN Avatar project as well as some smaller projects with interest from multiple departments within Rutgers Cancer Institute. We have added a Molecular Pathologist, Greg Riedlinger, whose expertise is pivotal to the screening process prior to DNA/RNA extraction for sequencing. The ORIEN consortium facilitates opening network-based clinical trials; Rutgers Cancer Institute recently opened the first ORIEN network clinical trial sponsored by Merck. Several Biorepository staff attend national meetings or participate in monthly conference calls for the purpose of sharing technical protocols for improved standardization of collection, processing, storage, and distribution procedures. Affiliation with this group has led to strong efforts within the Biorepository to work towards becoming accredited by the College of American Pathologists (CAP).
Establishing Live Cancer Tissues and Cell Lines to Support Innovative Cancer Models
In the past several years, innovative cancer models (e.g., organoid, PDX) have been increasingly used in cancer research, especially precision cancer therapeutics. The Biorepository works with members to provide high-quality live tissues and cells for developing these models.
Enhanced Pathology Tissue Analysis Technology
A CLIA-certified laboratory that provides all the tissue analysis technologies following federal CLIA regulations and CAP guidelines is now part of the Biorepository, with the required New Jersey Bioanalytical Laboratory License and CLIA certificate held by Dr. Marina Chekmareva. This certification has become essential to enable partnering with clinical investigators and industry for sponsored clinical trials. Board-certified pathologists provide interpretation of human tissues.
Last updated 05/14/2020