The Randomized Trial on the Clinical Management of ASCUS and LSIL of the Uterine Cervix is designed to: l) Determine whether human papillomavirus(HPV) testing can effectively triage women with a cytologic diagnosis of ASCUS (atypical squamous cells of undetermined significance) or LSIL (low-grade squamous intraepithelial lesion) 2) Develop clinical management guidelines and provide prognostic information for the ASCUS and LSIL diagnostic categories of the Bethesda System, and 3) Determine whether the cost of screening and treatment for the potential precursor lesions of cervical cancer can be reduced though improved triage. The Contractor shall be responsible for all aspects of the Trial involving direct contact with patients including patient outreach and recruitment, provision of screening tests and study interviews, randomization into one of three management study arms, and provision of followup and treatment based on study protocols. As a member of the Study Steering Committee, The contractor shall assist the preparation of a Procedures Manual to include the final protocol, data systems design, and study forms. The Contractor shall cooperate with the Study's three quality control groups, consultants, Coordinating Unit, and National Cancer Institute Project Officers.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN055156-008
Application #
6209665
Study Section
Project Start
1995-09-30
Project End
2001-09-29
Budget Start
1999-12-17
Budget End
2000-09-29
Support Year
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Magee-Women's Hospital of Upmc
Department
Type
DUNS #
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Wilson, Lauren; Pawlita, Michael; Castle, Phillip E et al. (2014) Seroprevalence of 8 oncogenic human papillomavirus genotypes and acquired immunity against reinfection. J Infect Dis 210:448-55
Gage, Julia C; Schiffman, Mark; Solomon, Diane et al. (2013) Risk of precancer determined by HPV genotype combinations in women with minor cytologic abnormalities. Cancer Epidemiol Biomarkers Prev 22:1095-101
Wilson, Lauren E; Pawlita, Michael; Castle, Phillip E et al. (2013) Natural immune responses against eight oncogenic human papillomaviruses in the ASCUS-LSIL Triage Study. Int J Cancer 133:2172-81
Marks, Morgan A; Castle, Philip E; Schiffman, Mark et al. (2012) Evaluation of any or type-specific persistence of high-risk human papillomavirus for detecting cervical precancer. J Clin Microbiol 50:300-6
Castle, Philip E; Gravitt, Patti E; Wentzensen, Nicolas et al. (2012) A descriptive analysis of prevalent vs incident cervical intraepithelial neoplasia grade 3 following minor cytologic abnormalities. Am J Clin Pathol 138:241-6
Campos, Nicole G; Castle, Philip E; Schiffman, Mark et al. (2012) Policy implications of adjusting randomized trial data for economic evaluations: a demonstration from the ASCUS-LSIL Triage Study. Med Decis Making 32:400-27
Castle, Philip E; Gage, Julia C; Wheeler, Cosette M et al. (2011) The clinical meaning of a cervical intraepithelial neoplasia grade 1 biopsy. Obstet Gynecol 118:1222-9
Castle, Philip E; Gutierrez, Erin C; Leitch, Sharon V et al. (2011) Evaluation of a new DNA test for detection of carcinogenic human papillomavirus. J Clin Microbiol 49:3029-32
Gage, Julia C; Schiffman, Mark; Solomon, Diane et al. (2010) Comparison of measurements of human papillomavirus persistence for postcolposcopic surveillance for cervical precancerous lesions. Cancer Epidemiol Biomarkers Prev 19:1668-74
Castle, Philip E; Schiffman, Mark; Wheeler, Cosette M et al. (2010) Impact of improved classification on the association of human papillomavirus with cervical precancer. Am J Epidemiol 171:155-63

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