DESCRIPTION (provided by applicant): Cervical cancer is the second most common cancer affecting women worldwide. Cervical cancer can be universally prevented when premalignant changes of the cervix are detected early and treated adequately. Colposcopy is the procedure used to evaluate women with abnormal Pap test results. Colposcopy is an extremely challenging clinical procedure and recent studies have demonstrated the inaccuracy of colposcopy. The current recommendation is to collect multiple cervical biopsies to improve the sensitivity of colposcopy. However, such a random approach increases cost, discomfort, and bleeding, anxiety and procedural time. We propose using polarized light for evaluating the epidermis and initial papillary dermis, the areas from which lower genital tract neoplasias arise. Polarized light enables deeper interrogation of the cervical microvasculature and gland clefts. Our preliminary work, based on analysis of digitized cervical images, demonstrated the ability of polarized light colposcopy to better discriminate Cervical Intraepithelial Neoplasia (CIN) 2/3 from CIN 1 when compared with unpolarized colposcopy. However, there are no published clinical trials that have prospectively evaluated the use of polarized light during colposcopy. The goal of this project is to develop advanced technology for cervical disease detection that improves the accuracy of identifying characteristic epithelial and vascular findings which define disease location, estimate the severity of disease and identify sites for obtaining representative histologic specimens while minimizing unnecessary histologic sampling. Our objective is to test the hypothesis that polarized light colposcopy will enhance and increase the detection of cancer precursors and improve the discrimination of neoplasias. This prospective clinical trial is designed to determine the efficacy of polarized light assisted colposcopy by examining three hundred women 18 years of age and older with a previously detected abnormal cervical cytologic abnormality or other indication for colposcopy at sites in Augusta, Georgia and Cusco, Peru. Cervical biopsies will be taken during unpolarized and polarized light colposcopy. Sensitivity and specificity, rates of neoplasia detection and agreement of colposcopic impression, biopsy intent and biopsy location will be determined. The impact of our study will be the development of a greatly improved device for use in cervical disease detection that will minimize unnecessary histologic sampling.
|Effective start/end date||3/18/11 → 2/28/14|
- National Institutes of Health: $194,445.00
- National Institutes of Health: $162,763.00