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RecruitingNCT06044662Updated Apr 11, 2024

Prognostic Value of Biomarkers in Polyneuropathy.

An observational study in Polyneuropathies, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Rigshospitalet, Denmark · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Biomarkers for prognosis of patients with polyneuropathy.

Read the 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.

02

Conditions studied

  • Polyneuropathies

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Keywords

  • polyneuropathy
  • biomarkers
  • cohort study
03

In context

Polyneuropathies

133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 53 observational studies indexed under Polyneuropathies.

Browse Polyneuropathies studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.

Browse Rigshospitalet, Denmark studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with acquired or hereditary polyneuropathy (ICD-10 diagnosis) confirmed at nerveconduction study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Minimum 18 years old.
  • Diagnosed with polyneuropathy, confirmed by nerve conduction study.
  • Can read and understand Danish.

Exclusion criteria

Exclusion Criteria:

  • Inability to perform physical tests due to comorbidity not associated to the patient's polyneuropathy.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Disease Severity

    Primary outcome is disease severity

    Time frame: 2 years

Secondary outcomes

  1. Patient Reported Outcomes (PROMs)

    Secondary outcome is patient reported outcomes.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Oct 2025, 24 months after the start.

Of 26 observational studies under Polyneuropathies, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 93. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2023
First posted
Sep 21, 2023
StartActual
Oct 27, 2023
Primary completionEst.
Oct 2025
CompletionEst.
Oct 2026
Last update
Apr 11, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06044662
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Louise Sloth Kodal (MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Sep 21, 2023
Start date
Oct 27, 2023
Primary completion
Oct 2025 (estimated)
Completion
Oct 2026 (estimated)
Last update
Apr 11, 2024

Study contacts

Tina Dysgaard, Dr.med.
Contact
Tina.dysgaard@regionh.dk
±45 35458077

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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