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JNCI Monographs 1999 1999(26):89-93;
© 1999 by Oxford University Press
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Journal of the National Cancer Institute Monographs, No. 26, 89-93, 1999
© 1999 Oxford University Press

IV. APPLICATIONS PANEL

Study-Design Issues in the Development of the University of Southern California Consortium's Colorectal Cancer Family Registry

Robert W. Haile, Kimberly D. Siegmund, W. James Gauderman, Duncan C. Thomas

Affiliation of authors: Department of Preventive Medicine,University of Southern California/Norris Comprehensive Cancer Center, Los Angeles.

Correspondence to: Robert W. Haile, Ph.D., Department of Preventive Medicine, University of Southern California/Norris Cancer Center, 1441 Eastlake Ave., MS#44, Rm. 4455, Los Angeles, CA 90033 (e-mail: haile{at}hsc.usc.edu).

The University of Southern California Consortium is a participating center in the National Cancer Institute's Collaborative Family Registry for Colorectal Cancer Studies (CFRCCS). Because data collection takes time, money, and effort, all of which are in short supply, we first defined our research objectives and then attempted to design our registry to enable us to address these objectives in an efficient manner. We decided on a family-based design, and our objectives are to characterize cloned genes that are generally accepted causes of colorectal cancer, to assess putative candidate genes, to map new genes, and to conduct prevention trials in high-risk subjects. For the gene characterization objectives, our primary aim is to estimate gene frequency and penetrance, with a secondary aim to investigate factors that may affect penetrance (allele-specific effects plus gene-gene and gene-environment interactions). We describe a multiple-stage design to select families into the registry. After a family is selected into the registry, we collect questionnaire data and blood samples on selected subjects only, and we tailor data collection decisions to each family (given who is affected and who is available) to optimize power per unit effort and cost. We also discuss practical decisions faced by our registry, including 1) defining a reference period for use in questionnaires; 2) deciding whether or not to establish cell lines and, if so, on whom; and 3) determining which cases should be tested for microsatellite instability. Finally, we address the appropriate use of data derived from high-risk clinics, within more broadly defined, population-based research.


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