Analysis of Markers in the Blood Correlated With Neuropathic Pain

February 5, 2019 updated by: Christoph Stein, MD

Neuropathic Pain: Association Between Phenotype and Biomarkers

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.

Study Overview

Status

Completed

Conditions

Detailed Description

On average, 3-8% of the German population suffers from neuropathic pain, which can occur after damage of somatosensory nerves in the peripheral or central nervous system. In terms of a "personalized" medicine, only a strict separation of neuropathic and chronic pain allows an individualized therapy to reduce pain severity and to enhance patients' quality of life.

Currently, the diagnosis of neuropathic pain is based on the medical history, the subjective description of somatosensory symptoms and the application of (non-genetic) diagnostic tests. To improve diagnosis and therapy of complex disorders for individual patients, novel methods are introduced based on flow cytometric (FACS) analysis of human immune cells or analysis of the human genome (genomics). Those techniques can support the identification of characteristic features indicating ongoing individual pathophysiologic processes in the body (biomarkers).

Often diseases are based on a complex relationship between genetics, environmental factors and the manifestation of the disease. To capture this complexity via genomics, phenotypical and genotypical data of high quality and detailed information about the study population are required.

This observational study includes patients suffering from painful and non-painful neuropathies associated with HIV-infection, diabetes mellitus and breast cancer. With the targeted application of validated questionnaires (such as the Brief Pain Inventory, Pain Catastrophizing Scale, Hospital Anxiety and Depression Scale, Ten-Item Personality Inventory, 36-Item Short Form Health Survey, and the Insomnia Severity Index) and parallel usage of genomics or FACS analysis of selected biomarkers in the blood, this study will provide information about the manifestation of certain genes or immune markers which are directly correlated to the symptoms of the disease. Additional performance of neuropsychological/cognitive tests and quantitative sensory testing (QST) will enhance the phenotypic profile. Identification of potential indicators could be utilized prospectively to precisely diagnose and effectively treat neuropathic pain.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Department of Anesthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitals, primary care clinics, resident physicians

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of gene expression
Time Frame: Assessment - 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christoph Stein, MD

Collaborators

deCODE genetics

Investigators

  • Principal Investigator: Christoph Stein, Prof., Department of Anesthesiology Charite

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeuroPain CBF_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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