Clincosm LogoSign in Get a demo

Prognostic Value of Biomarkers in Polyneuropathy.

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06044662
Collaborator
Danish Cancer Society (Other)
200
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Biomarkers for prognosis of patients with polyneuropathy.

Condition or Disease Intervention/Treatment Phase

    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: We 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Prognostic Value of Blood Biomarkers for Patients With Polyneuropathy.
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2025
    Anticipated Study Completion Date :
    Oct 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Disease Severity [2 years]

      Primary outcome is disease severity

    Secondary Outcome Measures

    1. PROM [2 years]

      Secondary outcome is patient reported outcomes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    • Polyneuropathy due to

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rigshospitalet, Denmark
    • Danish Cancer Society

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Louise Sloth Kodal, MD, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT06044662
    Other Study ID Numbers:
    • H-23032146
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Louise Sloth Kodal, MD, Rigshospitalet, Denmark
    polyneuropathy
    biomarkers
    cohort study
    Additional relevant MeSH terms:
    Polyneuropathies

    Study Results

    No Results Posted as of Sep 21, 2023