We hypothesize that the products of cellular oncogenes and antioncogen
es are biomarkers of events related to cancer risk. This study uses mo
noclonal antibody technology to examine serum proteins which are immun
ologically related to ras oncogene and epidermal growth factor recepto
r proteins. We measured the prevalence of ras- and epidermal growth fa
ctor receptor-related proteins in stored and freshly frozen serum from
cancer patients, male heavy smokers, and older healthy subjects. Work
emphasized the attainment of inter- and intraobserver agreement betwe
en independent readings of immunoblot gels. Although we achieved accep
table levels of agreement, we uncovered evidence for blood collection
and storage artifacts. Accounting for these artifacts, we compared 80
cancer patients and 188 middle-aged and older community controls and f
ound a strong relationship (odds ratio = 11.1; 95% confidence interval
, 6.0-20.6) between cancer and a M(r) 21,000 serum protein related to
the ras oncogene product. These results indicate the need and importan
ce of comprehensive pretesting of putative cancer biomarkers before us
e in applied or etiological epidemiological research.