LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,256
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the plasma free GAGome MCED test
研究概览
简要总结
LEVANTIS-0093A (LEV93A) is a prospective cohort observational clinical study to validate the plasma free GAGome MCED test in adults at high risk of developing cancer ("high-risk adults"), specifically in 55-80-year-old adults with significant smoking history.
LEV93A will use plasma biospecimens collected within the Yorkshire Lung Screening Trial Biomarker sub-study and corresponding participant data prospectively collected within the Yorkshire Lung Screening Trial (YLST) and the Yorkshire Kidney Screening Trial (YKST) all of which are sponsored by the University of Leeds and funded by Yorkshire Cancer Research (Award references: L403, L403B L403C), in collaboration with the University of Leeds, with the University of Manchester and with the Leeds Teaching Hospitals.
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
- 55 Years 至 80 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 the plasma free GAGome MCED test
时间窗: Within 365 days after the biosampling visit
Indicative of any-type cancer vs. no cancer diagnosis
次要结局
- Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)(Within 365 days after the biosampling visit)
- Sensitivity and specificity of the plasma free GAGome MCED test followed by low-dose computed tomography (LDCT)(Within 365 days after the biosampling visit)
- Sensitivity and specificity of LDCT followed by plasma free GAGome MCED test(Within 365 days after the biosampling visit)