Trial Information

Early Marker and Etiologic Studies in the PLCO Trial

The Division of Cancer Prevention and Control (DCP, formerly DCPC), under extramural
contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for
prostate, lung, colorectal and ovarian cancer (The PLCO Trial). In 1996 the NCI Executive
Committee approved the expansion of the PLCO Trial to collect additional materials and to
conduct additional studies. About 74,000 men and 74,000 women, aged 55-74 years, have been
randomized on a 50/50 basis into screening or usual care arms. Additional blood is
collected from screened subjects and saliva for buccal cells from control subjects.
Pathologic tissues are obtained for cases that develop cancer or selected related diseases
(e.g., colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk and
disease-related information is also collected, with confirmation of disease status from
medical records. Genetic, biochemical and questionnaire-based risk information will be
related to the development of cancer and other diseases in this population. Volunteers who
provide samples for these studies will not routinely receive their individual results from
the Additional Investigation. Subjects requesting such information, however, will be
provided with the research results. In 2009 the NCI Executive Committee approved the
Extended Follow-up of subjects beyond the original 13-year follow-up period. Participants
will be reconsented for the release of records to a single NCI-Designated Central Data
Collection Center (CDCC), which will administer the annual mailings containing the annual
study update questionnaire and a brief (1-2 page) risk factor questionnaire. Individuals who
do not consent to release their identifiers to the CDCC will be followed up passively
through linkage to state cancer registries and the National Death Index.

This protocol Review Application is for (1) the collaboration of intramural scientists in
the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies and (2)
the coordination, in collaboration with DCP, of the Extended Follow-up.