Prognostic Value of Biomarkers in Polyneuropathy.

NCT ID: NCT06044662

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-27

Study Completion Date

2026-10-31

Brief Summary

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Biomarkers for prognosis of patients with polyneuropathy.

Detailed Description

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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.

Conditions

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Polyneuropathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Louise Sloth Kodal

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Tina Dysgaard, Dr.med.

Role: CONTACT

±45 35458077

Facility Contacts

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Tina Dysgaard, Dr.mee

Role: primary

±45 35458077

Louise Kodal, MD

Role: backup

Other Identifiers

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H-23032146

Identifier Type: -

Identifier Source: org_study_id

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