Multimodal Spectroscopic Evaluation of Cervical Cancer

宫颈癌的多模态光谱评估

• 批准号: 7160598
• 负责人: Shabbir Bakir Bambot
• 金额: $ 69.08万
• 依托单位: GUIDED THERAPEUTICS
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-04-01 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7160598
• 关键词: biopsy; cervix; cervix neoplasms; clinical research; diagnosis; endoscopy; female reproductive system disorder diagnosis; lead; literature survey; neoplasm /cancer; performance; sectioning; tissues

DESCRIPTION (provided by applicant): Cervical Cancer is the second most common type of cancer in women worldwide and the leading cause of cancer related mortality in women in developing countries. Early detection and diagnosis can saves lives and reduce the burden on the national healthcare system. We have built a non-invasive research-prototype point-of-care device to detect early cancerous conditions of the uterine cervix. We have tested this prototype in a multi-center pre-pivotal study accruing data from more than 600 women for training our algorithm. We have now started our pivotal study using an FDA reviewed protocol and have collected data from 702 subjects as of this writing. We will also test a pre- production version of our device in this pivotal study. This device, which has now been designed and built as part of a fast track SBIR grant 4R44CA110149, is a cost and size reduced, portable, rugged and more user-friendly than the research prototype. It is identical to the commercial device without incurring the tooling costs necessary to enter the production phase. The current pivotal study data accrual from 720 subjects is funded by our prior Phase II grant award 2R44CA086626. However the FDA has recommended changes in our claims and claim benchmarks resulting in an increase in subject accrual to justify a PMA submission. In this Phase II continuation effort, we will accrue data from an additional 930 subjects. This additional accrual will give us the 1500 subject data required by FDA to meet our claim benchmarks. Upon completing this additional accrual we will continue with the remaining aims of our original grant award viz. validate the algorithm on all pivotal data and prepare and submit the clinical PMA application to the FDA. Cervical cancer is the second most common type of cancer in women worldwide and one of the leading causes of cancer related deaths in women in developing countries. Like all cancers, it is preventable if detected and treated early. Currently, the major obstacles to detection and treatment are inaccurate and painful tests and delays in obtaining results. Spectroscopic diagnosis has the potential of removing all of these obstacles. Thus it not only improves care and quality of life for women suffering from this cancer but also reduces the burden that this cancer poses on health care costs worldwide.

描述（由申请人提供）：宫颈癌是全球女性中第二常见的癌症类型，也是发展中国家女性癌症相关死亡率的主要原因。早期发现和诊断可以挽救生命，减轻国家卫生保健系统的负担。我们已经建立了一个非侵入性的研究原型点护理设备，以检测宫颈的早期癌症状况。我们已经在一个多中心的预枢纽研究中测试了这个原型，收集了600多名女性的数据来训练我们的算法。我们现在已经开始了我们的关键研究，使用FDA审查的方案，并收集了702名受试者的数据。我们还将在这个关键的研究中测试我们的设备的预生产版本。该设备现在已被设计和制造为快速跟踪SBIR拨款4R44CA110149的一部分，其成本和尺寸减小，便携，坚固耐用，比研究原型更加用户友好。它与商业设备相同，而不会产生进入生产阶段所需的工具成本。目前720名受试者的关键研究数据由我们先前的II期拨款2R44CA086626资助。然而，FDA建议对我们的索赔和索赔基准进行更改，导致受试者应计费用增加，以证明PMA提交的合理性。在这项II期持续研究中，我们将从额外的930名受试者中收集数据。这一额外的累积将为我们提供FDA要求的1500个受试者数据，以满足我们的索赔基准。在完成这一额外项目后，我们将继续实现原始拨款的剩余目标，即在所有关键数据上验证算法，并准备并向FDA提交临床PMA申请。子宫颈癌是全世界妇女中第二常见的癌症类型，也是发展中国家妇女癌症相关死亡的主要原因之一。像所有癌症一样，如果及早发现和治疗，它是可以预防的。目前，检测和治疗的主要障碍是不准确和痛苦的检测以及获得结果的延误。光谱诊断有可能消除所有这些障碍。因此，它不仅改善了患有这种癌症的妇女的护理和生活质量，而且还减轻了这种癌症对全世界卫生保健费用造成的负担。