Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy (PREDIMAG)
26 agosto 2026 aggiornato da: 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."
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
100
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Abderhmane Slioui
- Numero di telefono: +33 0492038953
- Email: slioui.a@chu-nice.fr
Backup dei contatti dello studio
- Nome: Mecheli Cavalli
- Numero di telefono: +33 0492035435
- Email: puma.ar@chu-nice.fr
Luoghi di studio
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Alpes Maritimes
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Nice, Alpes Maritimes, Francia, 06000
- Chu De Nice
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Contatto:
- Angela Puma
- Numero di telefono: +33 0492035435
- Email: puma.ar@chu-nice.fr
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Contatto:
- Abderhmane de Nice
- Numero di telefono: +33 0492038953
- Email: slioui.a@chu-nice.fr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
"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."
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Favorable Clinical Response at 12 Months (≥1-Point Decrease in INCAT Score)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Predictive performance of TLI according to treatment strategy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Mecheli Cavalli
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 settembre 2026
Completamento dello studio (Stimato)
31 dicembre 2026
Date di iscrizione allo studio
Primo inviato
26 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
26 agosto 2026
Primo Inserito (Effettivo)
31 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
31 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 26Neuro05
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .