NCT05590715招募中不适用
International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Stalicla SA
- 入组人数
- 1,500
- 试验地点
- 21
- 主要终点
- Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.
研究概览
简要总结
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants previously diagnosed with ASD (DSM-5)
- •Available well-documented health records within the first 2 years of life
- •Participants must have a parent or reliable caregiver who agrees to provide information about the participant
- •Participants willing and consenting or assenting to participate.
排除标准
- •Episode of fever (i.e. ≥100.5 °F or ≥ 38 °C) or clinically significant illness without fever (as judged by the investigator), within 10 days before any study assessment.
- •If the investigator assesses any unwillingness or any medical condition that may prevent the subject from completing this study.
结局指标
主要结局
Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.
时间窗: Day 0
A semi-structured medical questionnaire will be administered to collect clinical (sign and symptoms) and anthropomorphic features.
Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations
时间窗: Day 0
Better characterize subpopulations of ASD subjects and potentially identify/confirm a molecular signature specific of each subpopulation.
次要结局
未报告次要终点
研究者
研究点 (21)
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