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临床试验/NCT02037789
NCT02037789已完成不适用

A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain

University of Parma6 个研究点 分布在 5 个国家开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
试验地点
6
主要终点
GENETIC OUTCOME

研究概览

简要总结

Low back pain (LBP) is one of the most common medical problems encountered in daily life; it is related to disability and work absence and accounts for high economical costs in Western societies.

Low-back pain is a diverse group of mixed pain syndromes (neuropathic and nociceptive) with different molecular pathologies at different structural levels displaying similar clinical manifestations. Currently, there are limited biomarkers (mostly imaging) or clinical findings that can be used objectively to help the physician in precise anatomic diagnosis leading to the safest and most cost-effective treatment for the patient (reduction of direct and indirect costs and improvement of treatment efficacy).

The main aim of this trial is to identify all "omics biomarkers" associated with susceptibility to chronic/persistent LBP and its different pathophysiology.

详细描述

Retrospective observational multinational clinical study, with a case control design.

Investigators will compare "omic biomarkers" between patients with and without persistent chronic low back pain (CLBP).

"OMIC" biomarkers investigated will be genetics, glycomics and activomic. Genetics through GWA studies has already obtained important results in pain research; however concerning low back pain, there is not yet suitable genotype-phenotype correlations helpful to stratify patients.

Glycomics is an emerging field that has recently been identified as a priority for the next decade by the US National Academies of Science. Many common complex diseases will be associated with specific changes in glycan structures. In addition, common genetic polymorphisms influencing glycosylation and consequent differences in glycome composition could be important diagnostic and prognostic markers. The first studies reporting protein glycosylation in large human population samples have been recently published by partners in the consortium. Reliable identification of valid associations between specific glyco-phenotypes and predisposition for the development or progression of a specific disease requires analysis of thousands of patients.

Activomics: combines data about enzymatic activity of numerous numerous post-translational modification proteins in an integrated model which provides dynamic characterization of the current state of an organism. In this project information about numerous proteases, kinases, phosphatases and glycosidases will be collected and used to complement the existing phenotype information.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • evidence of clinically unstable disease;
  • severe psychiatric disorder (excluding mild depression) or mental impairment;
  • recent history ( < 1 year) of spinal fracture;
  • pain in the back due to spinal tumor or infection;
  • pregnancy

结局指标

主要结局

GENETIC OUTCOME

时间窗: 30 months

The primary objective is to recognize genetic variants associated with persistent CLBP patients compared to patients without chronic/persistent pain. Through a Genetic Wide Association Study (GWAS) investigators will correlate genetic variants associated with persistent CLBP in a wide, international population of European ancestry.

次要结局

  • STRATIFICATION OF OUR POPULATION(30 months)
  • GLYCOMIC AND ACTIVOMIC OUTCOME(30 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Allegri

MD

Azienda Ospedaliero-Universitaria di Parma

研究点 (6)

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