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Blood Biomarkers for Prognostic Stratification in Guillain-Barré Syndrome

10 november 2026 bijgewerkt door: Jose Juan Antonio Ibarra Arias, Anahuac University

Integration of a Blood Biomarker Panel for Prognostic Stratification in Guillain-Barré Syndrome: A Mexico-Spain Collaborative Study (BioGBS)

Guillain-Barré syndrome (GBS) is an acute immune-mediated peripheral neuropathy characterized by substantial variability in clinical severity, functional recovery, and pain outcomes. The lack of validated and accessible prognostic biomarkers limits early risk stratification and individualized rehabilitation strategies.

This observational, longitudinal, retrospective and prospective study aims to evaluate a panel of five blood biomarkers (EGR1, EGR2, GBP1, miR-29c, and Piccolo) and determine their association with functional recovery, pain trajectories, and neurophysiological characteristics in patients with GBS.

The study will include at least 70 patients with GBS and 70 healthy controls. Patients will undergo longitudinal clinical and molecular assessments across different disease stages, whereas healthy controls will provide a single blood sample for reference measurements. Gene and microRNA expression will be quantified using quantitative reverse transcription polymerase chain reaction (qRT-PCR), and serum Piccolo concentrations will be assessed using ELISA or validated immunoassays.

Clinical assessments will include the GBS Disability Scale, Medical Research Council (MRC) Sum Score, Functional Independence Measure (FIM), and validated pain questionnaires. Molecular and clinical data will be integrated using multivariable statistical analyses to identify prognostic molecular signatures and develop predictive models.

The project also aims to support external validation in Mexican populations through international collaboration with Spanish research institutions.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Guillain-Barré syndrome (GBS) is an acute immune-mediated polyradiculoneuropathy affecting the peripheral nervous system. It is characterized by heterogeneous clinical presentations, including progressive weakness, sensory disturbances, pain, autonomic dysfunction, and, in severe cases, respiratory failure. Although immunomodulatory treatments and multidisciplinary rehabilitation have improved clinical outcomes, predicting individual recovery trajectories remains challenging.

Current prognostic assessment relies primarily on clinical and electrophysiological parameters, which may not adequately capture the molecular mechanisms underlying immune activation, peripheral nerve injury, remyelination, and functional recovery.

Previous investigations conducted by the research group identified differential expression of EGR1, EGR2, GBP1, and miR-29c in peripheral blood mononuclear cells (PBMCs) obtained from patients with GBS. Differential serum concentrations of the presynaptic protein Piccolo were also identified, suggesting their potential relevance as molecular indicators of disease progression and recovery.

The BioGBS study aims to validate these five candidate biomarkers through longitudinal analysis and integration with clinical, functional, pain-related, and neurophysiological data.

The study will employ an observational, retrospective and prospective longitudinal design, including at least 70 patients diagnosed with GBS and 70 healthy controls. Patients will be assessed at four clinically defined stages: initial diagnosis before immunomodulatory treatment (T0), maximum clinical severity or nadir (T1), onset of sustained functional recovery (T2), and advanced recovery or discharge from rehabilitation (T3). Healthy controls will undergo a single baseline molecular assessment.

Gene expression levels of EGR1, EGR2, GBP1, and miR-29c will be quantified in PBMCs using qRT-PCR. Serum Piccolo concentrations will be determined using ELISA or validated immunoassays.

Functional outcomes will be assessed using the GBS Disability Scale, MRC Sum Score, and FIM. Pain severity and interference will be evaluated using the Brief Pain Inventory-Short Form (BPI-SF), while neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI). Electrophysiological findings will be incorporated when available.

Statistical analyses will include longitudinal mixed-effects models, multivariable regression, principal component analysis, unsupervised clustering, and receiver operating characteristic curve analysis. Predictive models will be developed to identify molecular signatures associated with favorable or unfavorable functional recovery and persistent pain. Internal cross-validation and correction for multiple comparisons will be performed when appropriate.

The study will integrate the existing Spanish TOSGB biological collection and collaborative research activities in Mexico. External validation in Mexican patients is planned to evaluate the transferability of the prognostic biomarkers across different populations and healthcare settings.

No experimental treatment will be assigned. All participants with GBS will receive standard medical care and rehabilitation according to routine clinical practice.

Studietype

Observationeel

Inschrijving (Geschat)

140

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Mexico
      • Mexico City, Mexico
        • Werving
        • Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
        • Contact:
  • Spanje
      • Toledo, Spanje
        • Werving
        • Hospital Nacional de Parapléjicos
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population will consist of patients aged 16 years or older with clinically and neurophysiologically confirmed Guillain-Barré syndrome, recruited from participating hospitals in Spain and Mexico. A comparison group of healthy volunteers aged 18 years or older, with a comparable age and sex distribution, will be included to establish reference biomarker measurements. Patients will undergo longitudinal follow-up, whereas healthy controls will undergo a single baseline assessment.

Beschrijving

Inclusion Criteria:

  • Diagnosis of Guillain-Barré syndrome based on clinical and neurophysiological criteria.
  • Age 16 years or older.
  • Availability of biological samples for molecular analysis.
  • Written informed consent.
  • Availability of longitudinal clinical data.

Exclusion Criteria:

  • Alternative diagnosis explaining the neurological manifestations.
  • Concomitant active autoimmune disease.
  • Severe systemic infection.
  • Previous unrelated immunosuppressive treatment.
  • Incomplete clinical data or absence of informed consent.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: OTHER

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Patients With Guillain-Barré Syndrome

Patients with clinically and neurophysiologically confirmed GBS undergoing longitudinal molecular, functional, pain-related, and neurophysiological assessments across different stages of the disease.
Diagnostische toets: Blood Biomarker Panel Assessment (EGR1, EGR2, GBP1, miR-29c, and Piccolo)

Peripheral blood samples will be collected from patients with Guillain-Barré syndrome and healthy controls to evaluate a panel of molecular biomarkers. Expression levels of EGR1, EGR2, GBP1, and miR-29c will be quantified in peripheral blood mononuclear cells using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Serum Piccolo concentrations will be measured using ELISA or validated immunoassays. Patients with Guillain-Barré syndrome will undergo longitudinal assessments at predefined clinical stages, whereas healthy controls will undergo a single baseline assessment. No experimental treatment will be administered, and routine clinical management will remain unchanged.
Healthy Controls

Healthy individuals without neurological or autoimmune disorders, selected to provide reference measurements for the candidate blood biomarkers. Controls will undergo a single baseline blood sample collection.
Diagnostische toets: Blood Biomarker Panel Assessment (EGR1, EGR2, GBP1, miR-29c, and Piccolo)

Peripheral blood samples will be collected from patients with Guillain-Barré syndrome and healthy controls to evaluate a panel of molecular biomarkers. Expression levels of EGR1, EGR2, GBP1, and miR-29c will be quantified in peripheral blood mononuclear cells using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Serum Piccolo concentrations will be measured using ELISA or validated immunoassays. Patients with Guillain-Barré syndrome will undergo longitudinal assessments at predefined clinical stages, whereas healthy controls will undergo a single baseline assessment. No experimental treatment will be administered, and routine clinical management will remain unchanged.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Guillain-Barré Syndrome Disability Score
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline

Change in functional disability measured using the GBS Disability Scale, ranging from 0 (normal health) to 6 (death). Higher scores indicate greater disability. Longitudinal changes will be assessed in relation to blood biomarker expression.

0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.

All assessment intervals are calculated from T0 (baseline). Clinical stages are determined according to the patient's disease progression and recovery status.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline
Change in Muscle Strength Assessed by the MRC Sum Score
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Change in muscle strength assessed using the Medical Research Council Sum Score, ranging from 0 to 60. Higher scores indicate better muscle strength. Longitudinal changes will be evaluated in association with molecular biomarker profiles.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Functional Independence Measure Score
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Functional independence measured using the Functional Independence Measure (FIM), ranging from 18 to 126. Higher scores indicate greater independence in activities of daily living.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Change in Pain Intensity Assessed by the Brief Pain Inventory
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Change in pain intensity measured using the Brief Pain Inventory-Short Form (BPI-SF), on a scale from 0 to 10, with higher scores indicating greater pain intensity.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Change in Pain Interference Assessed by the Brief Pain Inventory
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Change in the interference of pain with daily activities, measured using the BPI-SF on a scale from 0 to 10, with higher scores indicating greater interference.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Change in Neuropathic Pain Symptom Inventory Score
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Change in neuropathic pain symptoms assessed using the Neuropathic Pain Symptom Inventory (NPSI), with a total score ranging from 0 to 100. Higher scores indicate greater neuropathic pain severity.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Longitudinal Change in EGR1, EGR2, GBP1, and miR-29c Expression
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Relative expression of EGR1, EGR2, GBP1, and miR-29c in PBMCs measured using qRT-PCR and expressed as 2^-ΔCt or 2^-ΔΔCt. Associations with clinical recovery trajectories will be analyzed.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Longitudinal Change in Serum Piccolo Concentration
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Serum Piccolo concentration quantified using ELISA or a validated immunoassay and expressed in pg/mL or ng/mL, depending on assay specifications.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Prognostic Performance of the Combined Blood Biomarker Panel
Tijdsspanne: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Discriminative performance of a combined panel comprising EGR1, EGR2, GBP1, miR-29c, and Piccolo for identifying unfavorable functional recovery, evaluated using the area under the receiver operating characteristic curve (AUC).

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Requirement for Mechanical Ventilation
Tijdsspanne: From baseline (Day 1) through 12 months after baseline.

Proportion of patients requiring invasive mechanical ventilation during the acute phase of GBS and duration of ventilatory support when applicable.
From baseline (Day 1) through 12 months after baseline.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Anahuac University

Medewerkers

Hospital Nacional de Parapléjicos de Toledo

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2027

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

21 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

10 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 241/2018

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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