Diagnostic Biomarkers for Radicular Pain

根性疼痛的诊断生物标志物

• 批准号: 8261685
• 负责人: Lewis S. Hanna
• 金额: $ 71.94万
• 依托单位: CYTONICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8261685
• 关键词: Absenteeism at work; Adrenal Cortex Hormones; Adverse effects; Back Pain; Biological Assay; Biological Markers; Cauda Equina; Data; Degenerative Disorder; Diagnostic; Guidelines; Hospitals; Inflammatory; Injection of therapeutic agent; Intervention; Intervertebral disc structure; Location; Low Back Pain; Medical; Nerve; Neurologic; Neurologist; Occupations; Operative Surgical Procedures; Outpatients; Pain; Pain management; Pathway interactions; Patients; Phase; Physicians; Plant Roots; Prospective Studies; Publishing; Radiculopathy; Reagent; Resistance; Services; Specialist; Spinal; Steroids; Structure; Surgeon; Surgical Decompression; Syndrome; Testing; Vertebral column; clinical care; cost; disability; follow-up; interest; irritation; medical attention; meetings; public health relevance; tool

DESCRIPTION (provided by applicant): This is a proposal to collect the necessary data for FDA regulatory approval of the Cytonics assay as a diagnostic tool to identify patients who will respond to steroid injection therapy for LBP due to radiculopathy. Low back pain (LBP) syndromes include spinal degenerative conditions with and without nerve root or cauda equina irritation. These syndromes represent some of the most common reasons for patients to seek medical attention. LBP syndromes associated with neurological irritation are often effectively treated, whereas those not primarily associated with neurological irritation have proven resistant. The greatest current challenge in the clinical care of patients with LBP syndromes is identifying those who suffer from active neurological irritation and therefore may benefit from interventional therapies, such as corticosteroid injection (ESI). However, there is currently no validated test to discriminate between patients who will or will not respond to ESI. For example, only ~50% of the >10 million yearly epidural steroid injections successfully relieve pain. Many patients that don't respond to initial steroid injections will receive follow-up injections at the same or a different spinal location. These unnecessary injections are costly and have side effects. In Phase I, we developed and validated an assay that can prospectively identify patients who will respond to steroid treatment. Our Specific Aim in Phase II is to collect the necessary data for FDA regulatory approval of the Cytonics assay as a diagnostic tool to identify patients who will respond to steroid injection therapy for LBP due to radiculopathy. To achieve this Objective, we will carry out the following Tasks: Task #1: Validate our assay to meet FDA manufacturing guidelines. Task #2: Carry out a large prospective study appropriate for obtaining PMA clearance using our validated assay. Task #3: Prepare and submit a PMA to the FDA. The assay will be sold as a kit, complete with all of the reagents required for the assay. We will provide the diagnostic kit to CLIA labs that are interested in providing the testing service, many of which will be located in surgical hospitals or outpatient centers. We will utilize a network of medical product distributors to provide information on the diagnostic to spine surgeons, neurologist, and pain management specialists in an effort to encourage the use of the test for their patients. We will also publish and present extensively on results of using our product. Phase II will result in a diagnostic assay to be submitted for FDA approval. PUBLIC HEALTH RELEVANCE: This is a project to develop a diagnostic assay that helps physicians know when to use steroid injections for treating back pain. Currently, 10 million such injections are made each year at a cost of about $2000 per injection. Half of the injections are ineffective. Our assay will allow physicians to know when a patient will not respond to an injection, thereby avoiding the needless injections and saving about 10 billion dollars per year in ineffective treatments, as well as allowing the physician to focus on treating the patient more effectively.

描述（由申请人提供）：这是一份收集必要数据的提案，以便FDA监管部门批准Cytonics检测作为诊断工具，以识别因神经根病而对类固醇注射治疗LBP有反应的患者。腰痛（LBP）综合征包括有或没有神经根或马尾刺激的脊柱退行性疾病。这些症状是患者寻求医疗照顾的一些最常见原因。与神经刺激相关的腰痛综合征通常得到有效治疗，而那些非主要与神经刺激相关的腰痛综合征已被证明具有耐药性。目前，在腰痛综合征患者的临床护理中，最大的挑战是识别那些患有活动性神经刺激的患者，从而可能受益于介入治疗，如皮质类固醇注射（ESI）。然而，目前还没有有效的测试来区分患者是否会对ESI有反应。例如，每年在1000万名患者中，只有50%的硬膜外类固醇注射成功缓解疼痛。许多最初注射类固醇无效的患者将在同一或不同的脊柱位置接受后续注射。这些不必要的注射既昂贵又有副作用。在I期，我们开发并验证了一种检测方法，可以前瞻性地识别对类固醇治疗有反应的患者。我们在II期的具体目标是收集必要的数据，以便FDA监管部门批准Cytonics检测作为诊断工具，以确定因神经根病而对类固醇注射治疗LBP有反应的患者。为了实现这一目标，我们将执行以下任务：任务#1：验证我们的分析以符合FDA生产指南。任务#2：使用我们验证的分析方法进行适合获得PMA清除率的大型前瞻性研究。任务#3：准备并向FDA提交PMA。该检测将作为试剂盒出售，包括检测所需的所有试剂。我们将向有兴趣提供检测服务的CLIA实验室提供诊断试剂盒，其中许多实验室将设在外科医院或门诊中心。我们将利用医疗产品分销商网络向脊柱外科医生、神经科医生和疼痛管理专家提供有关诊断的信息，以鼓励他们的患者使用该测试。我们还将广泛发布和展示使用我们产品的结果。第二阶段将产生一种诊断分析，提交FDA批准。