Epithelial Cell Regulation and Transformation Program
Integrative Biology and Infectious Diseases Branch, DER, NIDCR
OBJECTIVE
We are seeking approval to use the contract mechanism of support in FY2010 to maintain a centralized salivary gland tumor biorepository at MD Anderson Cancer Center (MDACC) currently funded by NIDCR under the grant mechanism. This will ensure control of performance and deliverables. This biorepository would collect biospecimens and associated clinical data (e.g., tumor type and size, histological grade, evidence of metastasis, anatomic site, evidence of perineural invasion), generate cell lines from primary tumor tissues, catalogue and store in a centralized facility, and distribute materials to the research community upon request.
BACKGROUND
Salivary gland tumors are rare neoplasms with approximately 3,300 new cases reported per year in the US. While surgery is the main modality of treatment for these tumors, advanced unresectable primary, recurrent and metastatic tumors are generally fatal. There have been relatively few investigators working in the field and a critical mass of research tools for investigators to engage in this type of research has not been established.
In an effort to accelerate advances in basic and translational research in this field and ultimately improve public health, NIDCR led the effort to support the establishment of a centralized biorepository at an academic institution with known expertise in head and neck and salivary gland tumor biology and pathology. NIDCR identified Dr. Adel El-Naggar, a nationally and internationally recognized expert in salivary gland tumor biology and pathology to co-lead this effort with NIDCR. Dr. El-Naggar is an endowed professor at MD Anderson Cancer Center (MDACC) and is one of the most distinguished head and neck pathologists in the world. Dr. El-Naggar coordinated this effort through a consortium of contributing centers (Johns Hopkins Medical Institutions, Rhode Island Hospital, University of Virginia, University of Pittsburgh Medical Center, and University of California in San Francisco) that agreed to provide biospecimens to the biorepository. He identified a core number of experts in salivary gland pathology and biology who could help identify and catalogue biospecimens linked to diagnostic, pathologic, treatment, and outcome data. Using tissues provided by this consortium, the biorepository stores and catalogues fresh frozen salivary gland tumor tissues and paraffin blocks (with matched serum, saliva, lymphocytes, depending on their availability) as well as associated clinical data. The biorepository is also tasked with generating cell lines from the primary tumor tissues. A critical component of this biorepository is the maintenance of a robust database that facilitates tracking of collection, storage, distribution, and usage of biospecimens and cell lines. In addition, a secure website that would allow queries from researchers regarding the availability of biospecimens and other documents related to specimen acquisition, such as request forms and user guidelines, will be developed and posted on the NIDCR, NCI, NIH, and the biorepository websites.
The governance structure consists of a steering committee, a tissue utilization committee, and a bioinformatics and data management group. The steering committee establishes objectives, policies, and plans of action. For example, it develops management policies/procedures such as access policies and procedures; standard operating procedures for specimen collection, storage, and distribution. Its membership roster includes members from NIDCR, the biorepository, and a representative from NCI’s Office of Biorepositories and Biospecimen Research. In addition, it includes two rotating members, one from each contributing center with staggered membership terms.
The tissue utilization committee receives and reviews applications for biospecimen use, plans for tissue accrual and disbursement through the biorepository and ensures appropriate availability of tissues and prioritization of requests. It ensures that biospecimens are used for the most appropriate research and eliminates redundant studies. Its membership roster includes 3 academic scientists with expertise in biologically and epidemiologically-based cancer studies, as well as ad hoc reviewers, if specific expertise is required. In addition, it includes members from NIDCR, the biorepository, and one rotating member from the consortium not represented on the steering committee, as well as a representative from a patient advocacy group.
The bioinformatics and data management group supports all aspects of biospecimen resource including research participant enrollment and consent, collection of research participant data, quality control/quality assurance data security, reporting functions, and clinical annotations to the biospecimens. Its membership roster includes members from NIDCR, the biorepository, a bioinformatician, and one contributing center member.
To monitor the success of this initiative and to ensure that the NIDCR’s investment is benefiting the extramural research community, an evaluation process that will monitor the research publications by the requestors and NIH grants awarded to institutions requesting the biospecimens will be developed and integrated into the biorepository policies.
To date, this effort has been supported by NIDCR as a supplement to an existing grant to MDACC. We propose to continue to support these efforts under the contract mechanism with MDACC as the sole source in FY2010 for 5 years. At this time, this is the most optimal mechanism of support, allowing greater oversight and management for the operations of this biorepository, and most importantly, securing the collected specimens and associated information as a deliverable to the Government under the contract. This will ensure the availability of the specimens for future research. This funding mechanism was endorsed by the Office of General Counsel, DHHS, following a discussion with them concerning the NIH’s inherent interest in establishing a biorepository to enhance research on salivary gland tumors.