DoD 奖项 NF230020：代谢标志物的识别与神经鞘瘤的统计预测，用于快速诊断和手术切缘评估
国防部拨款NF230020：用于快速诊断和手术切缘评估的代谢标志物鉴定与MPNST统计预测
The goal of this clinical research study is to learn if a handheld Mass Spectrometry device (MasSpec Pen) can accurately distinguish between masses, neurofibroma, and normal tissue during surgery.
研究概览
详细说明
Primary Objectives:
Aim 1. Determine the metabolite and lipid profiles of MPNST, neurofibroma, and nerve tissues
Aim 2. Validate the handheld mass spectrometry device (MSPen-Orbitrap system) for MPNST and neurofibroma diagnosis and for intraoperative surgical margin evaluation
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Keila Torres, MD,PHD
- 电话号码：(713) 792-4242
- 邮箱：ketorres@mdanderson.org
学习地点
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Texas
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Houston、Texas、美国、77090
- 招聘中
- The University of Texas M. D. Anderson Cancer Center
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接触：
- Keila Torres, MD,PHD
- 电话号码：713-792-4242
- 邮箱：ketorres@mdanderson.org
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首席研究员：
- Keila Torres, MD,PHD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
For Aim 1: 100 neurofibromas and 104 MPNST snap-frozen, clinically and pathologically annotated samples have been identified. These have been collected under protocol LAB06-0851.
For Aim 2: We will evaluate the technology in the OR and enable surgeons to collect molecular data from a cohort of 60 patients undergoing resection of suspected or diagnosis of MPNST/neurofibroma (protocol: 2019-1118).
描述
Inclusion Criteria:
- This study will enroll approximately 60 participants diagnosed with either MPNST or neurofibroma who are undergoing surgical resection of an MPNST or neurofibroma as part of their standard of care.
- Age ≥ 1 years. Individuals younger than 18 years old will be included. For patients of age < 18 years, both parents' signatures will be requested.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
- Recurrent or primary disease.
- Patients who are > 18 years should have the ability to understand and the willingness to sign a written informed consent document.
- English and non-English speaking patients.
Exclusion Criteria:
- Adult patients with cognitive impairment requiring a legally authorized representative for consent.
- Patients under age 1 and neonates.
- Patients who are pregnant and undergoing surgery for MPNST are not eligible.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety and Adverse Events (AEs)
大体时间：Through study completion; an average of 1 year.
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Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Through study completion; an average of 1 year.
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合作者和调查者
调查人员
- 首席研究员：Keila Torres, MD,PHD、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.