Clinical Evaluation of Polarized Light Assisted Colposcopy

描述（由申请人提供）：宫颈癌是影响全球妇女的第二大常见癌症。如果宫颈癌前病变能及早发现并得到适当治疗，宫颈癌是可以普遍预防的。阴道镜检查是用于评估巴氏试验结果异常的妇女的程序。阴道镜检查是一项极具挑战性的临床程序，最近的研究表明阴道镜检查的不准确性。目前的建议是收集多个宫颈活检，以提高阴道镜检查的敏感性。然而，这种随机方法增加了成本、不适、出血、焦虑和手术时间。我们建议使用偏振光评估表皮和初始乳头状真皮，下生殖道肿瘤发生的地区。偏振光可以更深入地检查颈部微血管和腺体裂隙。我们的初步工作基于对数字化宫颈图像的分析，证明了与非偏振光阴道镜检查相比，偏振光阴道镜检查能够更好地区分宫颈上皮内瘤变（CIN）2/3与CIN 1。然而，目前还没有发表的临床试验，前瞻性地评估在阴道镜检查中使用偏振光。该项目的目标是开发宫颈疾病检测的先进技术，提高识别特征性上皮和血管发现的准确性，这些发现定义了疾病的位置，估计了疾病的严重程度，并确定了获得代表性组织学标本的部位，同时最大限度地减少了不必要的组织学采样。我们的目的是验证偏振光阴道镜检查将增强和增加癌症前体的检测并提高肿瘤的鉴别力的假设。本前瞻性临床试验旨在通过在奥古斯塔、格鲁吉亚和秘鲁的库斯科对300名18岁及以上既往检测到宫颈细胞学异常或其他阴道镜检查适应症的女性进行检查，确定偏振光辅助阴道镜检查的有效性。宫颈活检将在非偏振光和偏振光阴道镜下进行。将确定敏感性和特异性、肿瘤检出率和阴道镜印模一致性、活检意图和活检位置。我们研究的影响将是开发一种用于宫颈疾病检测的大大改进的设备，该设备将最大限度地减少不必要的组织学采样。

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.