ImmuneSense™ IBD Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 484
- 试验地点
- 6
- 主要终点
- Sensitivity and specificity of T-Detect IBD
研究概览
简要总结
This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase.
Sites selected to participate in the study will enroll participants in the either the Research phase or CV and AV phase. Research Phase will enroll participants in Cohort 1 Pre-diagnosis/+GI symptoms only.
CV and AV phase will be open to enrollment in parallel. CV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment, Cohort 3 Potential Cross-Reactive Diseases and Cohort 4 Healthy controls.
AV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment and Cohort 4 Healthy controls. Enrollment will be ongoing until sponsor notification for closure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity and specificity of T-Detect IBD
时间窗: Initial Study visit/Baseline
To evaluate the sensitivity and specificity of T-Detect IBD, by interrogating the peripheral T cell repertoire for TCRs enhanced in IBD, to aid in diagnosis of IBD. To evaluate the sensitivity and specificity of T-Detect IBD relative to endoscopy with biopsies. To evaluate the sensitivity and specificity of T-Detect IBD as a prognostic marker for medication response.
次要结局
- Future/Additional research(Initial Study visit/Baseline)