"Applying PapGene test for early ovarian cancer detection"

项目总结/摘要 项目1拟确定宫颈液基细胞学检测肿瘤细胞是否 通过巴氏刷（称为“PapGene”测试）和/或血液循环肿瘤DNA（ctDNA）的样本可以识别 早期和低容量卵巢高级别浆液性癌（HGSC）或其前体病变，浆液性输卵管癌 上皮内癌（STIC）。卵巢HGSC是卵巢上皮性肿瘤中最常见和侵袭性的类型， 癌由于缺乏有效的筛查工具，该病最常在晚期被发现。 我们假设卵巢癌细胞从卵巢肿瘤或STIC脱落到管腔中， 输卵管和子宫，并通过子宫颈管出口。我们还假设在入侵时 卵巢癌细胞和/或它们的DNA脱落到体循环中。项目1的总体目标是 评价分子细胞学检测（PapGene检测）单独或联合 联合循环肿瘤DNA液体活检试验（ctDNA试验），用于HGSC的早期检测。其他 还将评估样本采集方法，如子宫内膜刷拭。卵巢HGSC占 绝大多数卵巢癌死亡及其早期发现在过去一直是一项艰巨的任务。 开发一种可用于检测高风险个体中早期、低容量疾病的检测方法， 并最终作为一种筛选测试，将代表一个重大的医学进步。发展这种 创新测试，我们组建了一个多学科团队，并有机会获得独特的队列。我们建议 具体目标如下： 目标1。定义PapGene和ctDNA检测在检测卵巢癌中的性能特征 HGSC。 目标二。探索PapGene和ctDNA检测在检测前驱病变和早期（低水平） 卵巢癌风险增加的女性中的卵巢HGSC。 目标3：确定PapGene检测作为卵巢HGSC筛查工具的临床实用性， 前瞻性队列

Project Summary/Abstract Project 1 is proposed to determine whether detection of tumor cells from liquid-based cervical cytology specimens by Pap brush (called “PapGene” test) and/or circulating tumor DNA (ctDNA) from blood can identify early and low-volume ovarian high-grade serous carcinoma (HGSC) or its precursor lesion, serous tubal intraepithelial carcinoma (STIC). Ovarian HGSC is the most common and aggressive type of ovarian epithelial cancer. The disease is detected most often at an advanced stage due to the lack of effective screening tools. We hypothesize that ovarian cancer cells are shed from ovarian tumor or STIC into the lumen, transit through the fallopian tubes and uterus, and exit via the endocervical canal. We also hypothesize that upon invasion ovarian cancer cells and/or their DNA are shed into systemic circulation. The overall objective of Project 1 is to evaluate the clinical performance of a molecular-based cytology test (PapGene test), alone or in combination with circulating tumor DNA liquid biopsy test (ctDNA test), for early detection of HGSC. Other sample collection method such as endometrial brushing will also be evaluated. Ovarian HGSCs accounts for the vast majority of ovarian cancer deaths and its early detection has been a daunting task in the past. Development of a test that can be used for the detection of early, low-volume disease in high-risk individuals, and eventually as a screening test, would represent a significant medical advance. To develop this innovative test, we put together a multidisciplinary team and have access to unique cohorts. We propose the following specific aims: Aim 1. Define the performance characteristics of the PapGene and ctDNA tests in detecting ovarian HGSC. Aim 2. Explore the utility of PapGene and ctDNA test to detect precursor lesions and early (low- volume) ovarian HGSC in women with increased risk of ovarian cancer. Aim 3. Determine the clinical utility of the PapGene test as a screening tool for ovarian HGSC in a prospective cohort.