A -- Aberrant Crypt Foci Special Study

The National Cancer Institute (NCI) intends to negotiate with the Screening Centers of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial for an ancillary study of Aberrant Crypt Foci (ACF). The PLCO screening centers include: the University of Pittsburgh Cancer Institute, N01-CN-25511; Georgetown University, N01-CN-25522; Henry Ford Hospital, N01-CN-25512; Universitiy of Minnesota, N01-CN-25513; University of Colorado Health Science Center, N01-CN-25514; Straub Pacific Health Research Institute, N01-CN-25515; Washington University, N01-CN-25516; Marshfield Medical Research and Education Foundation, N01-CN-25518; University of Utah, N01-N-25514; and the University of Alabama, N01-CN-75022. The ACF ancillary study is a special study within the PLCO trial ato investigate the prevalance and natural history of aberrant crypt foci in the distal colon. Aberrant crypt foci may be precursors to colorectal adenomas and cancers. This solicitation is for the recruitment of 700 current PLCO participants for two examinations of the distal colon using a high resolution/magnifying sigmoidoscope. For laboratory analyses of biopsy specimens obtained from the ACF ancillary study, NCI intends to negotiate with the University of California at Los Angeles, N01-CN-25404. For the coordination of the ACF ancillary study, NCI intends to negotiate with Westat, Inc., N01-CN-25476. Study coordination includes meeting with NCI personnel to review progress and resolve problems; monitoring progress and protocol adherence at screening centers and preparing monthly progress reports, preparing a manual of operations and appropriate data entry and other forms for the study; creating and maintaining a data base of study data, and coordinating conference calls and providing minutes. Authority: 41 U.S.C. 253(c)(1), as set forth in the FAR 6.302-1. See Numbered Note 22.