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July 2009 • Number 36
   

Transitions in the PLCO Study

One of DCEG’s central missions is to develop infrastructure, resources, and strategic partnerships in molecular epidemiology across NCI, NIH, and the extramural community. Few studies embody this mission better than the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. This population-based randomized trial, which evaluates screening programs for prostate, lung, colorectal, and ovarian cancers, enrolled more than 150,000 healthy men and women, ages 55 to 74, at 10 screening centers nationwide between 1993 and 2001. Its design and data, results and research, and broadly based biospecimens make the PLCO study a premier resource for cutting-edge epidemiologic research for a wide variety of cancers. From the beginning, NCI’s Division of Cancer Prevention (DCP) and DCEG have effectively collaborated on the design, implementation, and oversight of all aspects of the study.

During the next few years, the majority of the participants will have completed their scheduled six years of screening and seven years of follow-up and will no longer be actively followed by DCP. The efforts of the screening centers that enrolled, screened, and followed the participants and the exceptional overall navigation by DCP, especially by Dr. Christine Berg, the project officer, have been integral in establishing the extensive data and biospecimens available in the PLCO study. For DCEG, the conclusion of the screening component of the study presents an opportunity to shape the collaborative long-term follow-up of participants. The conversion of the PLCO trial into a long-term cohort study, a strategy that has been successful in previous NCI studies, underscores the enormous value of this resource in the molecular epidemiology of cancer.

Photo of James Lacey, Ann Hsing, and Mark Purdue.

James Lacey, Ann Hsing, and Mark Purdue.

Ann W. Hsing, Ph.D., Hormonal and Reproductive Epidemiology Branch (HREB), James V. Lacey, Jr., Ph.D. (HREB), and Mark Purdue, Ph.D., Occupational and Environmental Epidemiology Branch (OEEB), have accepted the responsibility of leading the DCEG effort in the PLCO study after the retirement of Richard B. Hayes, D.D.S., Ph.D. (OEEB), the leader of DCEG’s PLCO efforts since the trial’s inception. Drs. Hsing, Lacey, and Purdue have been collaborating with DCP and the numerous stakeholders, both intramural and extramural, on the future direction of PLCO. They will be working to organize DCEG’s collaborative role in long-term follow-up, refine policies and procedures, and ensure that all systems are in place for intramural and extramural scientists to use the resources of the PLCO study.

—James V. Lacey, Jr., Ph.D., Ann W. Hsing, Ph.D., and Mark Purdue, Ph.D.

Future Directions for the PLCO Study

Biorepository: The PLCO study includes a wide variety of stored biospecimens (i.e., serum, plasma, buffy coat, red blood cells, whole blood, and buccal cells) for use in research projects conducted under PLCO Etiologic and Early Markers initiatives. The availability of serial blood-based specimens makes PLCO ideally suited for investigations of early-disease markers. Mark Purdue, Ph.D., Occupational and Environmental Epidemiology Branch, will lead efforts to oversee and optimize the use of these biospecimens. 

Tissue: Tumor tissue has been collected from PLCO participants who developed prostate, lung, colorectal, or ovarian cancer during the study. Future collections will focus on other tumors to expand the existing tissue microarrays and tissue cores that can be combined with other biospecimens, questionnaires, and screening examinations for insights into the entire spectrum of carcinogenesis. James V. Lacey, Jr., Ph.D., Hormonal and Reproductive Epidemiology Branch (HREB), will guide the expansion and exploration of these tissue resources.

Strategic Planning: Transformation of the PLCO trial into a long-term follow-up study will greatly enhance the value of PLCO in future molecular and genetic epidemiologic research. DCEG and DCP are collaboratively creating plans to continue participant follow-up, collect additional information on exposures and endpoints, and preserve open and fair access for intramural and extramural investigators. Ann W. Hsing, Ph.D. (HREB), will lead the strategic planning process to maintain the PLCO study as an excellent resource for the next generation of cutting-edge research. 

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