Observational Study of Urine Metabolites in the Diagnosis of Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,250
- 试验地点
- 4
- 主要终点
- Disease signal detection
研究概览
简要总结
The goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases.
This research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn's disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease.
The main questions it aims to answer are:
- Does the platform identify a disease signal within each disease cohort, compared to normal controls?
- How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years of age at time of enrollment.
- •Able and willing to provide a one-time urine sample and comply with all study procedures for the study.
- •Able to understand the study procedures, able to provide consent to participate in the study, and willing to authorize release of relevant protected health information by consenting to a HIPAA medical release form.
排除标准
- •Known to be pregnant.
- •A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.
结局指标
主要结局
Disease signal detection
时间窗: From date of enrollment to the end of sample analysis, up to 100 weeks
Disease signal detection quantification within each disease cohort, compared to normal controls.
Test performance measures
时间窗: From date of enrollment to the end of sample analysis, up to 100 weeks
Sensitivity and specificity/false-positive rate
次要结局
未报告次要终点