"Applying PapGene test for early ovarian cancer detection"

项目摘要/摘要 项目1是为了确定从宫颈液基细胞学中检测肿瘤细胞是否 通过巴氏刷检(称为Papgene检测)和/或血液中循环肿瘤DNA(CtDNA)的样本可以识别 早期低体积卵巢高级别浆液性癌(HGSC)或其前驱病变浆液性输卵管 上皮内癌(STIC)。卵巢HGSC是卵巢上皮细胞中最常见和最具侵袭性的类型 癌症。由于缺乏有效的筛查工具，这种疾病最常在晚期被发现。 我们假设卵巢癌细胞是从卵巢肿瘤或STIC脱落到管腔，通过 输卵管和子宫，并通过宫颈内管出口。我们还假设一旦入侵 卵巢癌细胞和/或它们的DNA进入体循环。项目1的总体目标是 评估基于分子的细胞学检测(Papgene检测)的临床表现，单独或联合 结合循环肿瘤DNA液体活检试验(ctDNA试验)，早期发现HGSC。其他 还将对子宫内膜刷检等样本采集方法进行评估。卵巢HGSCs占 过去，绝大多数卵巢癌死亡及其早期发现一直是一项艰巨的任务。 开发一种可用于检测高危个体早期低量疾病的检测方法， 最终作为一种筛查测试，将代表着一项重大的医学进步。发展这一点 创新的测试，我们组建了一个多学科的团队，并可以接触到独特的队列。我们建议 以下是具体目标： 目的1.明确Papgene和ctDNA检测卵巢的性能特点 HGSC. 目的：探讨Papgene和ctDNA检测在早期(低、中、低)病变诊断中的应用价值。 卵巢癌风险增加的女性中的卵巢HGSC。 目的3.确定Papgene试验作为卵巢HGSC筛查工具的临床应用。 未来的队列。

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.