NCI Announces Creation of Early Detection Research Network: Comprehensive Initiative Will Develop and Validate Early Detection Markers for Cancer
Advances in cancer research, including programs such as the Cancer Genome Anatomy Project and the Director's Challenge for Molecular Diagnostics, will aid in the discovery of a variety of molecules, proteins, genes, and other biological substances that researchers believe may be the earliest warning signals that normal cells are on the road to becoming cancerous. A major initiative being under taken by the National Cancer Institute (NCI) will assist in the translation of these discoveries into methods for detecting these warning signals, sometimes even before full-blown cancer can develop, by creating the first comprehensive network to develop and validate early detection markers for cancer.The Early Detection Research Network will be a foundation for collaborative research on molecular, genetic, and other biological "markers" of human cancer. The initiative, funded at $61 million over five years, will support the creation of a multicenter network to discover and coordinate the evaluation of biomarkers for the early detection of common cancers, such as prostate, breast, lung, colorectal, ovarian, and upper aerodigestive tract cancers. These biomarkers could be present in blood, urine, sputum, or tissues and could serve as indicators of early cancer or of risk for impending cancer.
"This network will link the discovery of a biomarker directly to the next steps in the process of creating an early detection test," said Barnett Kramer, M.D., deputy director of NCI's Division of Cancer Prevention. "Discovery leads to work that confirms and improves the accuracy of the marker, and then quickly to early clinical validation of the test. In the past, each part of this process has been somewhat isolated from the next step, slowing the progression to useful tools."
Similar to how people have unique signatures or fingerprints, each tumor cell has a set of unique, identifiable, molecular characteristics related to their role in the body. Since 1996, NCI has considered the need to define the "signatures" of cancer cells to be an extraordinary opportunity for immediate investment in cancer research, as outlined in the annual bypass budget proposals to the President. Over the past year, several review groups of outside experts who met to give advice to NCI endorsed the creation of a consortium to accelerate the progress being made in the area of molecular and genetic markers toward application in cancer prevention, early detection, and risk assessment.
"The creation of this network is an opportunity and a challenge to the scientific community which requested it," said Bernard Levin, M.D., vice president for cancer prevention at the University of Texas M. D. Anderson Cancer Center, Houston and co-chairman of one of the review groups. "By creating better tests to find cancer and perhaps even identifying the point at which to intervene to prevent cancer, we now have a mechanism that ultimately could be extremely beneficial to patients."
The Network will consist of four components: the Consortium for Biomarkers in Early Detection Research, the Steering Committee (made up of members of the network), the Advisory Committee (made up of outside experts), and the Data Management and Coordinating Center.
The Consortium for Biomarkers in Early Detection Research will consist of three scientific components: Biomarker Developmental Laboratories (mainly academic centers with an interest in translational molecular biology of carcinogenesis and pathogenesis), Biomarker Validation Laboratories (academic centers, service laboratories, or private industry groups that would develop tests that could be reliably performed by multiple laboratories), and Clinical and Epidemiologic Centers (organizations with access to patient populations, such as academic centers, HMOs, community hospitals, or Veterans Administration hospitals).
The objectives of the Early Detection Research Network include:
- development and testing of promising markers or technologies in institutions having the appropriate expertise in order to obtain preliminary information to guide further testing;
- timely early phase evaluation of promising biomarkers or technologies, including assessment of diagnostic predictive value, sensitivity, specificity, and whenever possible, medical benefits, risks, and harms.
- timely development of markers and expression patterns, sometimes of multiple markers simultaneously, which will serve as background information for later large-scale studies in the field of cancer early detection and screening;
- collaboration among academic and industrial leaders in molecular biology, molecular genetics, clinical oncology, computer science, public health, and others, for the development of high throughput (large volume at high speed), sensitive assay methods for biomarkers for early disease detection;
- conducting early phases of clinical/epidemiological studies to evaluate predictive value of the biomarkers; and
- encouraging collaboration and rapid dissemination of information among awardees to ensure progress and avoid fragmentation of effort.
Researchers interested in participating in the network should respond to a Request for Applications slated to be issued by NCI in early 1999. Selected organizations will then enter into a cooperative research agreement with the institute.
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