Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy (PREDIMAG)
2026年8月26日 更新者：Centre Hospitalier Universitaire de Nice
A Monocentric Retrospective Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy
"Anti-myelin-associated glycoprotein (anti-MAG) neuropathy is a rare dysimmune peripheral neuropathy, most commonly associated with an IgM monoclonal gammopathy.
Its course is generally slow but may lead to significant functional disability.
Despite therapeutic advances, including rituximab, intravenous immunoglobulins (IVIg), immunochemotherapy, and more recently Bruton tyrosine kinase inhibitors (BTKi), treatment response remains highly variable between patients.
The Terminal Latency Index (TLI), an electrophysiological parameter reflecting distal demyelination, is a recognized diagnostic marker of anti-MAG neuropathy.
However, its potential role as a predictive biomarker of treatment response remains insufficiently studied.
Identifying a simple, reproducible, and readily available biomarker that could predict treatment response would be of major clinical importance for personalized patient management and optimization of therapeutic strategies.
This monocentric retrospective study will analyze clinical, biological, and electrophysiological data from patients with anti-MAG neuropathy followed at Nice University Hospital (CHU de Nice) to assess the predictive value of baseline TLI for clinical response 12 months after treatment initiation."
研究概览
地位
尚未招聘
研究类型
观察性的
注册 (估计的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Abderhmane Slioui
- 电话号码：+33 0492038953
- 邮箱：slioui.a@chu-nice.fr
研究联系人备份
- 姓名：Mecheli Cavalli
- 电话号码：+33 0492035435
- 邮箱：puma.ar@chu-nice.fr
学习地点
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Alpes Maritimes
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Nice、Alpes Maritimes、法国、06000
- Chu De Nice
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接触：
- Angela Puma
- 电话号码：+33 0492035435
- 邮箱：puma.ar@chu-nice.fr
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接触：
- Abderhmane de Nice
- 电话号码：+33 0492038953
- 邮箱：slioui.a@chu-nice.fr
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
"Adult patients with documented anti-MAG activity-associated neuropathy, followed at the Reference Center for Rare Diseases of the Peripheral Nervous System at Nice University Hospital (CHU de Nice) between January 2005 and July 2025.
Planned number of participants: 100 patients."
描述
Inclusion Criteria:
- Documented anti-MAG IgM polyneuropathy: positive anti-MAG antibodies, associated with an IgM monoclonal gammopathy, and a compatible clinical phenotype.
- Complete and interpretable baseline ENMG assessment: an initial electroneuromyography (ENMG) examination allowing reliable calculation of the TLI in at least two motor nerves among the right median, ulnar, and common fibular nerves.
- The examination must include the distal motor latency, proximal motor conduction velocity, and compound muscle action potential (CMAP).
- Treatment with at least one established therapeutic strategy: treatment initiated at the center, including intravenous immunoglobulins (IVIg), rituximab, immunochemotherapy, Bruton tyrosine kinase inhibitors (BTKi), and/or symptomatic treatment.
- Available functional clinical assessment: a documented INCAT disability score at two predefined time points: baseline (before treatment initiation) and 12 months (±2 months) after treatment initiation.
- Consent to participate in the study.
Exclusion Criteria:
- Peripheral neuropathy associated with an IgM monoclonal gammopathy, with strictly negative anti-MAG antibody testing or no available anti-MAG antibody measurement.
- Incomplete or uninterpretable ENMG data preventing accurate calculation of the TLI for the nerves of interest (median and ulnar nerves).
- Absence of a formally documented INCAT score at baseline or within the 12-month assessment window.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Anti-myelin-associated glycoprotein (anti-MAG) neuropathy
This monocentric retrospective observational study will include 100 patients with anti-myelin-associated glycoprotein (anti-MAG) neuropathy followed at Nice University Hospital (CHU de Nice).
No additional intervention or modification of routine clinical care will be performed.
Clinical, biological, therapeutic, and electrophysiological data will be retrospectively collected from medical records and available archives.
Routinely performed electroneuromyography (ENMG) data will be analyzed, with particular emphasis on the Terminal Latency Index (TLI), calculated from available electrophysiological parameters according to the standard formula.
The predictive value of baseline TLI for clinical response to treatment at 12 months will be assessed.
Treatments received as part of routine care, including rituximab, IVIg, immunochemotherapy, and Bruton tyrosine kinase inhibitors (BTKi), will be recorded.
No treatment will be assigned or modified by the study.
Data will be pseudonymized and ent
|
This monocentric retrospective observational study will include 100 patients with anti-myelin-associated glycoprotein (anti-MAG) neuropathy followed at Nice University Hospital (CHU de Nice).
No additional intervention or modification of routine clinical care will be performed.
Clinical, biological, therapeutic, and electrophysiological data will be retrospectively collected from medical records and available archives.
Routinely performed electroneuromyography (ENMG) data will be analyzed, with particular emphasis on the Terminal Latency Index (TLI), calculated from available electrophysiological parameters according to the standard formula.
The predictive value of baseline TLI for clinical response to treatment at 12 months will be assessed.
Treatments received as part of routine care, including rituximab, IVIg, immunochemotherapy, and Bruton tyrosine kinase inhibitors (BTKi), will be recorded.
No treatment will be assigned or modified by the study.
Data will be pseudonymized and ente
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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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Favorable Clinical Response at 12 Months (≥1-Point Decrease in INCAT Score)
大体时间：12 months after treatment initiation
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Clinical response at 12 months, defined as a reduction of at least 1 point in the INCAT disability score from baseline.
This outcome will be used to assess the predictive value of the baseline Terminal Latency Index (TLI) for treatment response in patients with anti-MAG neuropathy.
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12 months after treatment initiation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Predictive performance of TLI according to treatment strategy
大体时间：12 months after treatment initiation.
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Assessment of the predictive performance of baseline TLI for clinical response at 12 months, stratified according to the treatment strategy received.
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12 months after treatment initiation.
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Correlation between TLI, anti-MAG antibody titer, and INCAT score evolution
大体时间：Baseline to 12 months after treatment initiation
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Assessment of the association between baseline TLI, quantitative anti-MAG antibody titer, and change in the INCAT disability score from baseline to 12 months.
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Baseline to 12 months after treatment initiation
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Optimal TLI threshold for predicting treatment response
大体时间：Baseline to 12 months after treatment initiation
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Determination of the optimal baseline TLI threshold for predicting clinical response at 12 months using Receiver Operating Characteristic (ROC) curve analysis and the Youden index
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Baseline to 12 months after treatment initiation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mecheli Cavalli
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年8月26日
首先提交符合 QC 标准的
2026年8月26日
首次发布 (实际的)
2026年8月31日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
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