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Prognostic Value of Biomarkers in Polyneuropathy.

The Prognostic Value of Blood Biomarkers for Patients With Polyneuropathy.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06044662
Enrollment
200
Registered
2023-09-21
Start date
2023-10-27
Completion date
2026-10-31
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyneuropathies

Keywords

polyneuropathy, biomarkers, cohort study

Brief summary

Biomarkers for prognosis of patients with polyneuropathy.

Detailed description

AIM: To investigate biomarkers' use as a prognostic tool in polyneuropathy patients. STUDY DESIGN: Prospective cohort study of patients with polyneuropathy. METHODS: 200 patients with polyneuropathy will be examined with physical tests, medical examination, questionnaires, and blood biomarkers at baseline and at 1-year follow-up, and 2-year follow-up. ANALYSIS: The investigators will calculate the odds of disease progression after 2 years depending on biomarkers levels at baseline using multiple logistic regression with sex and age adjustment. Diagnostic performance of the physical tests and biomarkers for prediction of disease progression will be assessed by Receiver Operating Characteristic Curve analysis with the area under the curve.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Minimum 18 years old. * Diagnosed with polyneuropathy, confirmed by nerve conduction study. * Can read and understand Danish.

Exclusion criteria

* Inability to perform physical tests due to comorbidity not associated to the patient's polyneuropathy.

Design outcomes

Primary

MeasureTime frameDescription
Disease Severity2 yearsPrimary outcome is disease severity

Secondary

MeasureTime frameDescription
Patient Reported Outcomes (PROMs)2 yearsSecondary outcome is patient reported outcomes.

Countries

Denmark

Contacts

Primary ContactTina Dysgaard, Dr.med.
Tina.dysgaard@regionh.dk±45 35458077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026