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FAQs

This page is designed to answer some of the common questions about NCI's Cancer Human Biobank (caHUB) initiative. We will update these Frequently Asked Questions (FAQs) as new information becomes available or new questions are submitted to us. If you don't find an answer to your question on this page, please send us an e-mail.

What are human biospecimens?

Biospecimens are samples of biological material, such as urine, blood, tissue, cells, DNA, RNA, and protein from humans. Biospecimens are often stored in a biorepository and are used for laboratory research or clinical purposes. Medical information may also be stored along with a written consent to use the samples in laboratory studies.

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What are biorepositories?

Biorepositories (or biobanks) are "libraries" where biospecimens are stored and made available for scientists to study for clinical (treatment) or research purposes.

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What is caHUB?

caHUB aims to modernize the field of biobanking by developing an infrastructure for collaborative biospecimen research and the production of evidence-based biospecimen standard operating procedures.

caHUB will make the resulting data, analysis, policy documents, and scientific tools publicly available to enable the community to collect biospecimens fit for specific scientific purposes.

caHUB will develop an infrastructure for collaborative biospecimen research by:
  • Designing, developing, and managing a national resource for biospecimen science and standardization research purposes
  • Adhering to the highest ethical and technical standards for biospecimen collection, storage, and dissemination
  • Developing and managing a network of biospecimen-contributing institutions
  • Standardizing and developing improvements to biospecimen science and best practices
  • Developing enabling technologies
  • Providing laboratory services and online access to resources
  • Fostering communication, collaboration, partnerships, education, and earning the public's trust
  • Evolving into a public-private partnership

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How will caHUB's infrastructure work?

The primary operating components of caHUB will consist of medical research and health care institutions for biospecimen collection, a pathology reference center, core biospecimen processing and analysis operation, a comprehensive and highly integrated informatics platform (e.g. , including patient clinical data, patient consent, biospecimen handling data, and molecular analysis), and a research and development program integrating the efforts underway within NCI's Biospecimen Research Network and NCI's Innovative Molecular Analysis Technologies Program.

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When will caHUB be launched?

The program will roll-out in three phases:

Development: 2009-2011
Implementation: 2012-2014
Production: 2015-Future

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What is NCI's funding to implement caHUB?

NCI is allocating $23.5 million that the Institute received from the American Recovery and Reinvestment Act (ARRA) of 2009 for development of caHUB. These funds will jumpstart the initiative and provide initial start-up costs.

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What factors are currently driving the critical need in cancer for standard operating procedures (SOPs) for biospecimen collection, processing, and storage?

One of the most difficult problems in clinical research is the limited availability of high-quality human biospecimens and associated clinical data. This issue has been repeatedly identified by the scientific community as a leading obstacle to progress in post-genomics cancer research which seeks to understand the biology of cancer at its most fundamental molecular level. Biospecimens used for genomic research need to meet a stringent set of collection, processing and storage criteria so that the DNA and RNA extracted from them can be used by advanced sequencing and analysis technologies.

The biospecimens quality issue was identified as a major challenge during the early phases of The Cancer Genome Atlas (TCGA) project - a national effort to systematically explore the entire spectrum of genomic changes involved in human cancers using innovative genome analysis technologies. Researchers involved with TCGA found that 65 percent of the tumor biospecimens acquired for genomic sequencing and characterization were deemed inadequate quality for TCGA research purposes.

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How does the lack of access and availability of high-quality biospecimens affect cancer research?

Biospecimens are critical to cancer research because they contain an extraordinary amount of biological information, written in the language of cells, genes and proteins that can identify the biological characteristics of cancer cells over time. Researchers can correlate these patterns with the clinical picture of how different patients experience progression of their disease or how the disease responds to therapies delivered.

Critical to making progress in our fight against cancer is the availability of high-quality biospecimens, which is dependent upon standardized handling processes, removal of competitive barriers to biospecimen access, and biospecimen research science that explores how collection, processing, storage and transport procedures impact the biospecimen's molecular characteristics and ultimate usefulness in cancer research.

Because the current biobanking system has fallen short in all of these areas, there is a considerable and problematic shortage in the availability of high-quality, well-documented biospecimens for cancer research. As a result, the progress and pace of research is hindered as researchers often question the quality of the biospecimens available to them and, therefore, the reliability of their research results. Scientists are compelled to restrict the scope of or curtail their projects due to limited availability of biospecimens fit for their purposes. These issues must be addressed urgently in order to enable advances in cancer research and patient care.

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What are the incentives for existing biobanks to participate in caHUB?

Existing biobanks will receive a number of benefits from participating in the caHUB network. These benefits include:
  • Making biospecimens available to a larger scientific community
  • Quality control of biospecimens
  • Adoption of national SOPs for collecting, processing, and storing biospecimens
  • Guidance and educational opportunities for biobank personnel and managers

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Why should caHUB be a government-developed biobank as opposed to a private resource?

The problems around biospecimen standard operating procedures have such a large public health impact that they warrant national attention. NCI's extramural research programs and outside biomedical research organizations rely on networks for shared biospecimens and are significantly affected by the variability of human biospecimens. Large-scale genomic and proteomic studies such as The Cancer Genome Atlas (TCGA) and the Clinical Proteomic Technologies for Cancer (CPTC) projects require sufficient numbers of quality-controlled biospecimens to enable reproducible, statistically significant comparisons of control and research subject samples.

caHUB will serve as a reliable source of policies, data and standards enabling collection of well annotated known-quality human biospecimens across the research community. caHUB will also assist biorepositories in developing standard operating procedures and best practices for protecting human subjects in biospecimen research.

The caHUB initiative capitalizes on resources already developed by the NCI, including the Biospecimen Research Network and the NCI Best Practices for Biospecimen Resources, both of which were developed to address challenges around biospecimen quality and process standardization. caHUB will also serve a critical role in coordinating a systematic approach to biospecimen science. OBBR and caHUB will work to facilitate communication and coordination across sectors through an extensive network of partners which includes government agencies, private industry, and non-profit and advocacy organizations.

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Are there funding opportunities for existing biobanks and medical institutions that are interested in joining the caHUB network?

Currently, there are no available funding opportunities. All contractual awards for establishment of the caHUB infrastructure have been made. However, partnerships and collaborative research opportunities will be critical components of caHUB.

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