Clinical trial NCT03862365: Exploring the Genetics of Neuropathic Pain
Official title: Exploring the Genetics of Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuropathic Pain
Genetic Predisposition
Polyneuropathies
Keywords: reliability
validity
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Helse Stavanger HF
name: St. Olavs Hospital
name: University Hospital of North Norway
name: University of Oxford
name: Danish Pain Research Center
name: Oslo Metropolitan University
First posted: 2019-03-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that are referred for suspected distal symmetric polyneuropathy and meet the inclusion criteria, will be included in the project. Furthermore, there will be collected blood tests from patients with definite and probable polyneuropathy.

Brief summary: In the present study the investigators will search for new genetic variants relevant for the development of neuropathic pain.

Detailed description: Neuropathic pain is defined as "pain caused by a lesion or disease of the somatosensory nervous system". Neuropathic pain is a huge health problem worldwide, with an estimated prevalence of 7-8 % in the general population. In the present study the investigators will search for new genetic variants relevant for the development of this type of pain.

Peripheral nerve lesions only progress to neuropathic pain in some patients, yet is not completely understood why or how. Genetic studies of patients with rare neuropathic disorders have been important for elucidating novel molecular mechanisms of neuropathic pain, and new drugs for neuropathic pain are now being developed based on these findings. By using genetic association studies, one may identify new genetic variants which may help to identify key molecular mechanisms for a larger group of patients with neuropathic pain.

This project will use existing population-based cohorts, as well as establish a specific registry and biobank for patients with neuropathy in order to address these specific needs. This will allow the investigators to identify a large number of individuals with probable neuropathic pain and individuals with pain-free peripheral neuropathy (disease controls). International collaboration will contribute to study a large group of patients, which will be important in order to reach the project's goals. The results from the project are expected to increase current knowledge on the mechanisms of neuropathic pain, opening up new opportunities for innovative and improved treatments.

Dissemination of results will be organized in close collaboration with patient representatives, and will be done regularly throughout the course of the project. The will focus both on internal dissemination to the participating hospitals, and external dissemination through participation in conferences, submissions to scientific journals and by publishing patient-friendly information booklets and proactively informing media outlets and patient organizations.

Eligibility criteria: Inclusion Criteria:

1. The patient is between 18 and 70 years old.
2. The patient has consented.
3. The patient is referred for evaluation of possible distal symmetric polyneuropathy (DSPN).
4. The patient has filled out the questionnaires.

Exclusion Criteria:

1. The patient is too sick to participate (eg. bedridden, fever).
2. The patient is unable to consent (eg. dementia, speech problems, psychiatric disorder).
3. Inflammatory acute polyneuropathy.

Primary outcomes:
measure: Genetic variants associated with neuropathic pain.
timeFrame: Baseline
measure: Phenotype; neuropathic pain yes/no
timeFrame: Baseline
measure: Phenotype; subgroup analysis of patients with neuropathic pain based on grading of pain
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Helse Stavanger HF
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Oslo University Hospital
name: John Anker Zwart, M.D.
role: STUDY_CHAIR
affiliation: University of Oxford
name: David Benett, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland University Hospital
name: Ina Hjelland, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo Metropolitan University
name: Margreth Grotle, Pr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Helse Stavanger HF
name: Marie Bu Kvaløy, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs Hospital
name: Trond Sand, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Norway
name: Sissel Løseth, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish pain research senter
name: Troels Jensen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: