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NCT06044662 Clinical Trial

Prognostic Value of Biomarkers in Polyneuropathy.

Polyneuropathies Clinical Trial

Official title:
The Prognostic Value of Blood Biomarkers for Patients With Polyneuropathy.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06044662
Other study ID # H-23032146
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 27, 2023
Est. completion date October 2026

Study information
Verified date April 2024
Source Rigshospitalet, Denmark
Contact Tina Dysgaard, Dr.med.
Phone ±45 35458077
Email Tina.dysgaard@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Biomarkers for prognosis of patients with polyneuropathy.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date October 2026
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease Severity Primary outcome is disease severity 2 years
Secondary Patient Reported Outcomes (PROMs) Secondary outcome is patient reported outcomes. 2 years
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