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Abnormal Cervix Cells: CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells

Research Question:
Can the presence of human Papillomavirus (HPV) and certain chemical substances (biomarkers) in cervical cells can help identify which women with a cytologic diagnosis of Atypical Glandular Cells (AGC) have a benign condition and which have a pre-cancerous condition or an invasive cancer that requires surgical removal?

Basic Study Information

Purpose:
The main purpose of this study is to determine whether the presence of Human Papillomavirus (HPV) and certain chemical substances (biomarkers) in cervical cells can help identify which women with a cytologic diagnosis of AGC have a benign condition and which have a pre-cancerous condition or an invasive cancer that requires surgical removal. Each biomarker will be tested in both cervical cells (obtained similar to a Pap specimen) and tissue (removed during a surgical procedure). Results of the testing will be compared to see which biomarker or combination of biomarkers is the most accurate at identifying which women with a cytologic diagnosis of AGC have a benign condition and which have a pre-cancerous condition or an invasive cancer. An additional goal of this study is to study DNA (genetic material) recovered from tissue to determine if there are changes in the DNA that can tell which women with a diagnosis of AGC have a benign condition and which have a pre-malignant condition or invasive cancer.

Location: Cancer Center
Study Web URL:  https://clinicaltrials.gov/ct2/show/NCT00892866?term=GOG0237&rank=1
Study Reference #: CGYC-16051

Lead Researcher (Principal Investigator)

Lead Researcher: Richard Moore

Study Contact Information

Study Coordinator: Laura Mitchell
Phone: (585) 275-7763
Email: Laura_Mitchell@urmc.rochester.edu

Additional Study Details

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