Cytology-Free POC Cervical Cancer Diagnostics for Global Health

无细胞学 POC 宫颈癌诊断促进全球健康

• 批准号: 9028137
• 负责人: JENNIFER SUSAN SMITH
• 金额: $ 50万
• 依托单位: BECTON, DICKINSON AND COMPANY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9028137
• 关键词: Academy; Antibodies; Antigens; Bedside Testings; Biological; Biological Assay; Blood; Brazil; Businesses; Cancer Detection; Cancer Diagnostics; Cancer Hospital; Cancer cell line; Cancerous; Cause of Death; Cervical; Cervical Cancer Screening; Cervical dysplasia; Cessation of life; China; Chinese People; Clinical; Clinical Oncology; Collaborations; Colposcopy; Complex; Country; Cytology; Detection; Developed Countries; Developing Countries; Development; Diagnosis; Diagnostic; Diagnostic tests; Differential Diagnosis; Engineering; Feces; Goals; Government; Health system; Healthcare; Human Papillomavirus; Human Resources; Immune response; Immunoassay; Incidence; Income; Kenya; Lesion; Location; Magnetism; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Medical; Medical Device; Medical Research; Nanotechnology; Neoplasms; Optics; Outcome; Pap smear; Performance; Preparation; Prevention program; Proteins; Reader; Reagent; Reporting; Research Infrastructure; Research Institute; Resources; Role; Running; Sampling; Science; Sensitivity and Specificity; Signal Transduction; Site; Specificity; Specimen; Staging; Surface; Swab; Symptoms; Technology; Testing; Time; Triage; Urine; Validation; Water; Woman; assay development; base; biomarker panel; clinical application; clinical research site; cost; design; diagnostic assay; experience; global health; health care delivery; improved; instrument; low and middle-income countries; member; mortality; multidisciplinary; multiplex detection; nanoparticle; novel; performance tests; point of care; point-of-care diagnostics; programs; protein biomarkers; public health relevance; screening; targeted biomarker; tumor progression

 DESCRIPTION (provided by applicant):HPV-associated cervical cancer is among the leading causes of death in women worldwide, with more 500,000 cases and 275,000 deaths annually. While repeated screening through frequent use of the Papanicolaou (Pap) smear has drastically reduced the incidence and mortality of cervical cancer in developed nations, the vast majority of cervical cancer-related deaths occur in low- and middle-income countries with minimal healthcare infrastructure. Cytology-based prevention programs have proven to be extremely difficult to implement and sustain in low-resource settings, and as a result over 85% of new cervical cancer cases originate in developing countries. The lack of adequate infrastructure for traditional cytology-based screening combined with the presentation of cervical cancer, where symptoms are not present until the cancer is in an advanced stage, emphasize the clinical need for a screening test appropriate for low resource settings. Development of a reliable Point-of-Care (POC) test with high sensitivity and specificity has the ability to reduce the incidence and mortality of cervical cancer worldwide. We propose to develop a novel nanotechnology- based diagnostic assay platform to detect cervical cancer progression in low-resource settings. This multiplex assay platform, which is currently being developed for non-oncology applications by Becton Dickinson (BD), is designed to be low-cost, easy to use, and inexpensive. We propose to adapt this platform to develop a highly specific diagnostic test that will screen women who do not need treatment and identify women with cervical lesions who need to be referred for colposcopy. The diagnostic test is based on Surfaced Enhanced Raman Scattering (SERS) technology, that enables detection of multiple targets in a complex sample without the need for washing or purification. The test and analysis is completed in less than 30 minutes, provides a "sample-in- answer-out" workflow, making the platform ideal for a "screen and treat" test in low-resource settings. Diagnostic development and validation will be done in close collaboration with a multidisciplinary team with expertise in HPV and cervical cancer screening as well as clinical oncology. By combining BD's experience in assay development, global healthcare delivery, and regulatory approval with the clinical expertise of other team members, the team has the expertise required to develop and validate a POC cervical cancer test for low resource settings. In addition to BD assay development, engineering, global healthcare delivery, and regulatory personnel, the team includes Dr. Jennifer S. Smith (UNC-Chapel Hill), Dr. Douglas Clark (UNM), Dr. Mark Stoler (UVA Health System), Dr. Scott McClelland (UW), and clinical validation site leaders including Dr. You-Lin Qiao (Chinese Academy of Medical Sciences), Dr. Nelly Mugo (Kenya Medical Research Institute), Dr. Jose Fregnani (Barretos Cancer Hospital), and Dr. Adhemar Longatto-Filho (Barretos Cancer Hospital, Brazil).

 描述（由适用提供）：与HPV相关的宫颈癌是全球妇女的主要死亡原因之一，每年有500,000例病例和275,000例死亡。尽管经常使用Papanicolau（PAP）涂片重复筛查，但已大大降低了发达国家的宫颈癌的事件和死亡率，但绝大多数与宫颈癌相关的死亡发生在低收入和中等收入国家，具有最小的医疗保健基础设施。事实证明，基于细胞学的预防计划在低资源环境中实施和维持非常困难，因此，超过85％的新宫颈癌病例源于发展中国家。缺乏用于基于传统细胞学的筛查的足够基础设施以及宫颈癌的呈现，在癌症处于晚期阶段，不存在症状，这强调了对适合低资源设置的筛查测试的临床需求。具有高灵敏度和特异性的可靠护理（POC）测试的开发具有降低全球宫颈癌的发病率和死亡率的能力。我们建议开发一种新型的基于纳米技术的诊断测定平台，以检测低资源环境中的宫颈癌进展。该多重测定平台目前正在由Becton Dickinson（BD）为非肿瘤学应用程序开发，旨在低成本，易于使用且便宜。我们建议适应该平台，以开发高度特定的诊断测试，该测试将筛选不需要治疗的女性，并识别需要引用阴道镜检查的宫颈病变的女性。诊断测试基于表面增强的拉曼散射（SERS）技术，可在复杂样本中检测多个目标，而无需洗涤或纯化。测试和分析在不到30分钟的时间内完成，提供了一个“回答”的工作流程，使平台在低资源设置中的“屏幕和治疗”测试是理想的。诊断开发和验证将与具有HPV和宫颈癌筛查以及临床肿瘤学专业知识的多学科团队密切合作。通过将BD在评估开发，全球医疗保健交付和监管部门批准方面的经验与其他团队成员的临床专业知识相结合，该团队拥有开发和验证POC宫颈癌测试所需的专业知识。 In addition to BD assay development, engineering, global healthcare delivery, and regulatory personnel, the team includes Dr. Jennifer S. Smith (UNC-Chapel Hill), Dr. Douglas Clark (UNM), Dr. Mark Stoler (UVA Health System), Dr. Scott McClelland (UW), and clinical validation site leaders including Dr. You-Lin Qiao (Chinese Academy of Medical Sciences), Dr. Nelly Mugo (Kenya Medical研究所），何塞·弗雷格纳尼（Jose Fregnani）博士（巴雷托斯癌症医院）和阿达玛·朗托托·菲尔霍（Adhemar Longatto-Filho）博士（巴西巴雷托斯癌症医院）。