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Exploring the Genetics of Neuropathic Pain (GeNeup)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03862365
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : September 14, 2021
Sponsor:
Collaborators:
Haukeland University Hospital
Helse Stavanger HF
St. Olavs Hospital
University Hospital of North Norway
University of Oxford
Danish Pain Research Center
Oslo Metropolitan University
Information provided by (Responsible Party):
Kristian Bernhard Nilsen, Oslo University Hospital

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

Condition or disease Intervention/treatment
Neuropathic Pain Genetic Predisposition Polyneuropathies Genetic: Nerve conduction Studies

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Exploring the Genetics of Neuropathic Pain
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 1, 2027
Estimated Study Completion Date : December 31, 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
Polyneuropathy with pain
Clinical and diagnostic test evaluation for the establishment of polyneuropathy with pain.
 Genetic: Nerve conduction Studies
Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
Other Name: Genetical analysis
Polyneuropathy without pain
Clinical and diagnostic test evaluation for the establishment of polyneuropathy without pain.
 Genetic: Nerve conduction Studies
Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
Other Name: Genetical analysis
Diabetic polyneuropathy with pain
Clinical and diagnostic test evaluation for the establishment of diabetic polyneuropathy with pain.
 Genetic: Nerve conduction Studies
Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
Other Name: Genetical analysis
Diabetic polyneuropathy without pain
Clinical and diagnostic test evaluation for the establishment of diabetic polyneuropathy without pain.
 Genetic: Nerve conduction Studies
Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
Other Name: Genetical analysis
Carpal tunnel syndrome with pain
Clinical and diagnostic test evaluation for the establishment of carpal tunnel syndrome with pain.
 Genetic: Nerve conduction Studies
Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
Other Name: Genetical analysis
Carpal tunnel syndrome without pain
Clinical and diagnostic test evaluation for the establishment of carpal tunnel syndrome without pain.
 Genetic: Nerve conduction Studies
Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
Other Name: Genetical analysis


Outcome Measures
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Primary Outcome Measures :
  1. Genetic variants associated with neuropathic pain. [ Time Frame: Baseline ]
    Relevant genotypes will be found using genome-wide association study (GWAS) methodology, ie. with no assumptions regarding which genetic variants that may be relevant (no hypotheses regarding specific variants). This is going to be conducted by using array genotyping (SNPs) in order to identify genetic variants that might be associated with neuropathic pain. Genetic variants will be defined and named according to standard practice, without any room for local or study specific adaptations.

  2. Phenotype; neuropathic pain yes/no [ Time Frame: Baseline ]
    Patients will be divided in two groups; neuropathy With pain (= neuropathic pain) and neuropathy without pain. For definition of neuropathic pain, the Neupsig guidelines (Finnerup et al, Pain 2016) will be used.It is estimated that about 600 patients will be included yearly for this purpose

  3. Phenotype; subgroup analysis of patients with neuropathic pain based on grading of pain [ Time Frame: Baseline ]
    Patients with neuropathic pain will be further subdivided in groups based on pain reports. Pain will be graded using validated questionnaires. The "Brief Pain Inventory-BPI" (Cleeland et al, 1994) questionnaire will be used as primary resource for pain grading, on a scale from 0 to 10 (0: no pain, 1-3: mild pain, 4-10: strong pain).


Biospecimen Retention:   Samples With DNA
Whole blood + blood for Expression analysis

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862365


Contacts
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Contact: Kristian B. Nilsen, M.D +4791372241 uxnikq@ous-hf.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Ina Hjelland, M.D.    +4755975000    ina.hjelland@helse-bergen.no   
Oslo University Hospital Recruiting
Oslo, Norway, 0450
Contact: Kristian B. Nilsen, M.D.    +4791372241    uxnikq@ous-hf.no   
Contact: Ioannis Kitsos, M.D.    +4722117769    ioakit@ous-hf.no   
Helse Stavanger HF Recruiting
Stavanger, Norway, 4011
Contact: Marie Bu Kvaløy, M.D.    +4751518430    marie.bu.kvaloy@sus.no   
University Hospital of North Norway Recruiting
Tromsø, Norway, 9019
Contact: Sissel Løseth, M.D.    +4777627102    sissel.loseth@unn.no   
St. Olavs Hospital Recruiting
Trondheim, Norway, 7030
Contact: Trond Sand, M.D.    +4772576006    trond.sand@ntnu.no   
Sponsors and Collaborators
Oslo University Hospital
Haukeland University Hospital
Helse Stavanger HF
St. Olavs Hospital
University Hospital of North Norway
University of Oxford
Danish Pain Research Center
Oslo Metropolitan University
Investigators
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Study Chair: John Anker Zwart, M.D. Oslo University Hospital
Principal Investigator: David Benett, M.D. University of Oxford
Principal Investigator: Ina Hjelland, M.D. Haukeland University Hospital
Principal Investigator: Margreth Grotle, Pr. Oslo Metropolitan University
Principal Investigator: Marie Bu Kvaløy, M.D. Helse Stavanger HF
Principal Investigator: Trond Sand, M.D. St. Olavs Hospital
Principal Investigator: Sissel Løseth, M.D. University of North Norway
Principal Investigator: Troels Jensen, M.D. Danish pain research senter
More Information
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Additional Information:

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Responsible Party: Kristian Bernhard Nilsen, Senior Consultant, phd, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03862365    
Other Study ID Numbers: 2017/1593
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristian Bernhard Nilsen, Oslo University Hospital:
reliability
validity
Additional relevant MeSH terms:
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Neuralgia
Polyneuropathies
Disease Susceptibility
Genetic Predisposition to Disease
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations
Disease Attributes
Pathologic Processes