Analysis of Markers in the Blood Correlated With Neuropathic Pain

NCT02208206 | Completed

• 1 other identifier: NeuroPain CBF_01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze associations between symptoms and specific markers in the blood in patients suffering from neuropathic pain linked to diseases of different origin. Such markers could be utilized in the future for precise diagnosis of neuropathic pain and might lead to targeted pain treatment.

Conditions

Neuropathy

Keywords

Neuropathic pain; Phenotype; Genotype; Biomarkers; HIV; Diabetes mellitus; Breast cancer; Genomics; Quantitative sensory testing

Outcome Measures

Primary Outcomes (1)

• Analysis of gene expression

  Investigation of associations between phenotypic and genotypic data. Patients with chronic painful and non-painful neuropathy will be phenotyped in detail using validated questionnaires related to pain (Brief Pain Inventory and Numeric Rating Scale), mental health (Pain Catastrophizing Scale and Hospital Anxiety and Depression Rating Scale), personality (Ten-Item Personality Inventory) and quality of life (36-Item Short Form Health Survey and Insomnia Severity Index). Optional, a set of neuropsychological/cognitive tests and quantitative sensory testing (QST) will be performed. DNA will be isolated from patients' blood samples and analyzed for genetic variants which might have an effect on the development of neuropathic pain. Once, phenotypic and genotypic data are available they will be associated with each other with the goal to find genetic variants tied to pain phenotypes and which might serve as novel DNA biomarkers for neuropathic pain.

  Assessment - 1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitals, primary care clinics, resident physicians

You may qualify if:

• HIV-associated neuropathy
• Sufficient knowledge of the German language

You may not qualify if:

• Co-incident severe central nervous system diseases
• Major psychiatric conditions
• Dementia
• Limited mental capacity or limited German language skills
• Intoxication with alcohol or recreational drugs within the last 48 hours of the study

Sponsors & Collaborators

• Christoph Stein, MD: lead
• deCODE genetics: collaborator

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum

MeSH Terms

Conditions

Neuralgia; Diabetes Mellitus; Breast Neoplasms

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christoph Stein, Prof.

  Department of Anesthesiology Charite

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical director

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 4, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

DE (1)