PolyneuropathiesNCT06044662
Prognostic Value of Biomarkers in Polyneuropathy.
An observational study of Polyneuropathies, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Biomarkers for prognosis of patients with polyneuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathies
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Oct 2023to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acquired or hereditary polyneuropathy (ICD-10 diagnosis) confirmed at nerveconduction study.
Who may be able to join
- Minimum 18 years old.
- Diagnosed with polyneuropathy, confirmed by nerve conduction study.
- Can read and understand Danish.
Who cannot join
- Inability to perform physical tests due to comorbidity not associated to the patient's polyneuropathy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet
Copenhagen, 2100
Tina Dysgaard, Dr.mee, ±45 35458077, Tina.dysgaard@regionh.dk
Louise Kodal, MD, Louise.boensdorff.sloth.01@regionh.dk
About this study
Official title: The Prognostic Value of Blood Biomarkers for Patients With Polyneuropathy.
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.
- Conditions
- Polyneuropathies
- Keywords
- polyneuropathy, biomarkers, cohort study
- Medical subject headings
- Polyneuropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Severity
Primary outcome is disease severity
Measured: 2 years
Secondary outcomes (1)
Patient Reported Outcomes (PROMs)
Secondary outcome is patient reported outcomes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start27 Oct 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathiesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Sloth Kodal, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044662
- Sponsor's protocol ID
- H-23032146
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Blood Biomarkers for Patients With Polyneuropathy.
- ClinicalTrials.gov ID
- NCT06044662
- Acronym / sponsor ID
- H-23032146
- Conditions
- Polyneuropathies
- Keywords
- polyneuropathy, biomarkers, cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biomarkers for prognosis of patients with polyneuropathy.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acquired or hereditary polyneuropathy (ICD-10 diagnosis) confirmed at nerveconduction study.
Key inclusion criteria (3 listed)
- Minimum 18 years old.
- Diagnosed with polyneuropathy, confirmed by nerve conduction study.
- Can read and understand Danish.
Key exclusion criteria (1 listed)
- Inability to perform physical tests due to comorbidity not associated to the patient's polyneuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease Severity
Time frame: 2 years
Primary outcome is disease severity
1 secondary outcome
Patient Reported Outcomes (PROMs)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyneuropathies, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tina Dysgaard, Dr.med. (±45 35458077, Tina.dysgaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Severity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.