"Applying PapGene test for early ovarian cancer detection"

“应用 PapGene 检测进行早期卵巢癌检测”

• 批准号: 10222604
• 负责人: Nickolas Papadopoulos
• 金额: $ 25.61万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-18 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10222604
• 关键词: Adnexal Mass; Age; Age-Years; Aneuploidy; Biopsy Specimen; Blood; Blood Circulation; Blood specimen; Breast; Cancer Etiology; Carcinoma; Carcinoma in Situ; Cervical; Cessation of life; Characteristics; Clinical; Clinical Management; Clinical Trials; Cytology; DNA; Data; Denmark; Detection; Development; Diagnosis; Disease; Early Diagnosis; Endometrial; Enrollment; Ensure; Epithelial ovarian cancer; Family history of; Future; Gynecology; Health system; Hospitals; Human Papillomavirus; Individual; Institution; Lesion; Link; Liquid substance; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Malignant neoplasm of ovary; Mammalian Oviducts; Medical; Methods; Molecular; Mutation; Mutation Detection; Oncologist; Operative Surgical Procedures; Ovarian; Ovary; Pathologist; Pathology; Pennsylvania; Performance; Pilot Projects; Plasma; Process; Prospective cohort; Public Health; Reporting; Reproducibility; Risk; Salpingo-Oophorectomy; Sampling; Screening for Ovarian Cancer; Screening for cancer; Screening procedure; Sensitivity and Specificity; Serous; Site; Somatic Mutation; Specificity; Specimen; Standardization; Syndrome; TP53 gene; Testing; Time; Tissues; Tube; United States; Universities; Uterus; Woman; base; biobank; cancer cell; cancer therapy; case control; cohort; detection test; follow-up; high risk; innovation; liquid biopsy; mortality; multidisciplinary; mutant; neoplasm registry; neoplastic cell; ovarian neoplasm; personalized medicine; risk stratification; sample collection; screening; tool; tumor; tumor DNA; Adnexal Mass; Age; Age-Years; Aneuploidy; Biopsy Specimen; Blood; Blood Circulation; Blood specimen; Breast; Cancer Etiology; Carcinoma; Carcinoma in Situ; Cervical; Cessation of life; Characteristics; Clinical; Clinical Management; Clinical Trials; Cytology; DNA; Data; Denmark; Detection; Development; Diagnosis; Disease; Early Diagnosis; Endometrial; Enrollment; Ensure; Epithelial ovarian cancer; Family history of; Future; Gynecology; Health system; Hospitals; Human Papillomavirus; Individual; Institution; Lesion; Link; Liquid substance; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Malignant neoplasm of ovary; Mammalian Oviducts; Medical; Methods; Molecular; Mutation; Mutation Detection; Oncologist; Operative Surgical Procedures; Ovarian; Ovary; Pathologist; Pathology; Pennsylvania; Performance; Pilot Projects; Plasma; Process; Prospective cohort; Public Health; Reporting; Reproducibility; Risk; Salpingo-Oophorectomy; Sampling; Screening for Ovarian Cancer; Screening for cancer; Screening procedure; Sensitivity and Specificity; Serous; Site; Somatic Mutation; Specificity; Specimen; Standardization; Syndrome; TP53 gene; Testing; Time; Tissues; Tube; United States; Universities; Uterus; Woman; base; biobank; cancer cell; cancer therapy; case control; cohort; detection test; follow-up; high risk; innovation; liquid biopsy; mortality; multidisciplinary; mutant; neoplasm registry; neoplastic cell; ovarian neoplasm; personalized medicine; risk stratification; sample collection; screening; tool; tumor; tumor DNA

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.

项目摘要/摘要 提出了项目1来确定是否从液体基宫颈细胞学检测肿瘤细胞 Pap Brush的标本（称为“ Papgene”测试）和/或血液中循环肿瘤DNA（CTDNA）可以识别 早期和小体积卵巢高级浆液性癌（HGSC）或其前体病变，浆液管 上皮内癌（Stic）。卵巢HGSC是最常见和侵略性的卵巢上皮类型 癌症。由于缺乏有效的筛查工具，最常在高级阶段发现该疾病。 我们假设卵巢癌细胞从卵巢肿瘤或STIC脱落到管腔中，通过 输卵管和子宫，并通过宫颈管出口。我们还假设在入侵时 卵巢癌细胞和/或其DNA被脱落到系统性循环中。项目1的总体目标是 评估基于分子的细胞学测试（PAPGENE测试）的临床性能，单独或中 结合循环肿瘤DNA液体活检试验（CTDNA测试），以早期检测到HGSC。其他 还将评估样品收集方法（例如子宫内膜刷牙）。卵巢HGSCS的帐户 过去，绝大多数卵巢癌死亡及其早期发现是过去一项艰巨的任务。 开发可用于检测高风险个体早期，小体外疾病的测试， 有时作为筛查测试将代表重大的医疗进步。开发这个 创新的测试，我们组建了一个多学科团队，并可以使用独特的同伙。我们建议 遵循特定目的： 目标1。在检测卵巢时定义papgene和ctDNA测试的性能特征 HGSC。 AIM 2。探索Papgene和CtDNA测试的效用，以检测前体病变和早期（低 - 体积）卵巢HGSC的卵巢癌风险增加的女性。 目标3。确定papgene测试作为卵巢HGSC的筛查工具的临床实用性 潜在队列。