Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 998
- 试验地点
- 1
- 主要终点
- Salivary miRNA profile
研究概览
简要总结
The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.
详细描述
The central aim of this project is to validate a panel of expressed microRNA (miRNA) in the saliva of children identified at risk for developing ASD by the MCHAT-R. Further, this study aims to assess the value of the current panel as an adjunctive test that may increase specificity of MCHAT-R positive results, or affirm clinical diagnoses alongside the ADOS or other objective assessments.
The primary endpoints of this study are as follows:
- Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with ASD from their non-ASD peers.
- Assess stability of the salivary microtranscriptome diagnosis over time, and interrogate longitudinal microtranscriptome levels relative to neuropsychological measures.
Secondary endpoints are the identification of microtranscriptome features whose concentrations correlate with ASD endophenotypes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 24 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at enrollment: 24 months to 48 months (inclusive)
- •MCHAT-R score of 3 or greater
- •Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc)
排除标准
- •confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence.
- •history of extreme pre-term birth (< 32 weeks gestation)
- •wards of the state
- •Autistic subjects with known syndromic autism (attributed to a known genetic mutation)
结局指标
主要结局
Salivary miRNA profile
时间窗: at the time of collect (from 18m to 6 years of age)
Measures of miRNA abundance in saliva
次要结局
- Measures of early intellectual development(At time of enrollment (from 18m to 6 years of age))
- Measure of autistic behavior(At time of enrollment (from 18m to 6 years of age))
- Measures of adaptive function(At time of enrollment (from 18m to 6 years of age))
研究者
Frank A Middleton
Principal Investigator/Associate Professor
State University of New York - Upstate Medical University