Early Marker and Etiologic Studies in the PLCO Trial

The Division of Cancer Prevention and Control (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). 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, are being randomized on a 50/50 basis into screening or usual care arms. Additional blood will be collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues will be obtained for cases that develop cancer or selected related diseases (e.g., colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk information will also be collected. 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 their test results. This protocol Review Application is for the collaboration of intramural scientists in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies.

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.

• INCLUSION CRITERIA:

Men and women aged 55-74 years.

Subjects who do not have a prior history of PLCO tumors and have not undergone routine screening.