Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
研究概览
简要总结
Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting the motor neuron. Currently, there is no diagnostic test and no examination that can predict the evolution of this pathology. The search for diagnostic and prognostic biomarkers is therefore essential for a better understanding of the pathophysiology of ALS, which remains poorly understood, and also for better clinical management. The ocular surface, made up of liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a biomarker in ALS
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with clinically defined or probable primary ALS according to Airlie House criteria(1)
- •Familial or sporadic form
- •≥18 years of age
- •Patient affiliated with a social security plan
- •Informed consent signed by the patient
排除标准
- •Motor neuron disease mimicking ALS
- •Pregnant or breastfeeding woman
- •Treatment that may have a neuroprotective effect
- •Any eye drops or treatments that may interfere with tear production
- •Lens wearer
- •Eye surgery ≤3 months
- •Any ocular pathology other than ametropia, oculomotor disorder, amblyopia
- •Any general pathology other than ALS with ocular repercussions
- •Protective measure of guardianship or curators
- •Control group selection criteria:
- •Inclusion Criteria:
- •No diagnosed neurological pathology
- •≥18 years of age
- •Patient affiliated with a social security plan
- •Informed consent signed by the participant
- •Exclusion Criteria:
- •Pregnant or breastfeeding woman
- •Treatment likely to have a neuroprotective effect
- •Any eye drops or treatments that may interfere with tear production
- •Lens wearer
- •Eye surgery ≤3 months
- •Any ocular pathology except ametropia, oculomotor disorder, amblyopia
- •Any general pathology with ocular repercussions
- •Protective measure of guardianship or curator
结局指标
主要结局
Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
时间窗: Baseline
Once the composition in metabolites in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.
Metabolome profile in tears for the diagnosis and prognosis of ALS.
时间窗: Baseline
Once the composition in metabolites (i.e. tear metabolome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabolome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker
Lipidome profile in tears for the diagnosis and prognosis of ALS.
时间窗: Baseline
Once the composition in lipids (i.e. tear lipidome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker
Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
时间窗: Baseline
Once the composition in lipids in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.
次要结局
- Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry(Baseline)
- Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry(Baseline)