NCT06044662

Brief Summary

Biomarkers for prognosis of patients with polyneuropathy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2023Oct 2026

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 27, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

September 13, 2023

Last Update Submit

April 9, 2024

Conditions

Polyneuropathies

Keywords

polyneuropathybiomarkerscohort study

Outcome Measures

Primary Outcomes (1)

  • Disease Severity

    Primary outcome is disease severity

    2 years

Secondary Outcomes (1)

  • Patient Reported Outcomes (PROMs)

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma will be extracted for analysis for known blood biomarkers of nerve damage (Neurofilament light chain, neurofilament heavy chain, Growth/Differentiation Factor 15, and Nerve Growth Factor), immunological biomarkers, and for proteomics to find new biomarkers.

MeSH Terms

Conditions

Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Tina Dysgaard, Dr.med.

CONTACT

±45 35458077Tina.dysgaard@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

October 27, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations

DK(1)