Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy (PREDIMAG)
2026년 8월 26일 업데이트: 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."
연구 개요
상태
아직 모집하지 않음
연구 유형
관찰
등록 (추정된)
100
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Abderhmane Slioui
- 전화번호: +33 0492038953
- 이메일: slioui.a@chu-nice.fr
연구 연락처 백업
- 이름: Mecheli Cavalli
- 전화번호: +33 0492035435
- 이메일: puma.ar@chu-nice.fr
연구 장소
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Alpes Maritimes
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Nice, Alpes Maritimes, 프랑스, 06000
- Chu De Nice
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연락하다:
- Angela Puma
- 전화번호: +33 0492035435
- 이메일: puma.ar@chu-nice.fr
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연락하다:
- Abderhmane de Nice
- 전화번호: +33 0492038953
- 이메일: slioui.a@chu-nice.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
"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."
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Favorable Clinical Response at 12 Months (≥1-Point Decrease in INCAT Score)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Predictive performance of TLI according to treatment strategy
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mecheli Cavalli
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2026년 9월 1일
연구 완료 (추정된)
2026년 12월 31일
연구 등록 날짜
최초 제출
2026년 8월 26일
QC 기준을 충족하는 최초 제출
2026년 8월 26일
처음 게시됨 (실제)
2026년 8월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 26일
마지막으로 확인됨
2026년 8월 1일
추가 정보
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