Prognostic Value of Biomarkers in Polyneuropathy.

Recruiting

• Conditions: Polyneuropathies

• Registration Number: NCT06044662
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Study Start: 2023-10-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Severity	2 years	Primary outcome is disease severity

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes (PROMs)	2 years	Secondary outcome is patient reported outcomes.

Trial Locations

Locations (1)

Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark