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NCT Number: NCT06044662

Prognostic Value of Biomarkers in Polyneuropathy.

Biomarkers for prognosis of patients with polyneuropathy.

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Key information

Conditions

Polyneuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Louise Kodal, MD

CONTACT

[email protected]

Tina Dysgaard, Dr.mee

CONTACT

[email protected]

±45 35458077

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Disease Severity

    Time frame: 2 years

    Primary outcome is disease severity

Secondary outcomes

  1. Patient Reported Outcomes (PROMs)

    Time frame: 2 years

    Secondary outcome is patient reported outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Tina Dysgaard, Dr.med.

CONTACT

[email protected]

±45 35458077

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

The Prognostic Value of Blood Biomarkers for Patients With Polyneuropathy.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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