LEVANTIS-0087A: GAGomes for Multi-Cancer Early Detection in Asymptomatic Adults (LEV87A)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9,170
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the combined free GAGome MCED test
研究概览
简要总结
LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to validate the diagnostic performance of free GAGome-based tests for multi-cancer early detection (MCED) in adults asymptomatic for cancer and with no recent history of cancer.
详细描述
Multi-cancer early detection (MCED) could prevent 26% of all cancer-related deaths - an effect larger than averting all deaths from breast cancer alone. However, a societal program to implement MCED requires a practical, noninvasive, and affordable diagnostic modality that is sensitive and specific to all forms of cancers. Liquid biopsies represent front-runner modalities to this end but virtually all of them rely on genomics biomarkers, typically circulating free DNA (cfDNA), which capture <20% of cancers in stage I. In addition, they miss certain cancer types that shed little cfDNA, like brain or genitourinary tumors. Pilot studies show that free glycosaminoglycan profiles in plasma and urine, or free GAGomes, were promising noninvasive biomarkers of cancer metabolism that detected over a third of stage I cancers across 14 types, including brain and genitourinary tumors.
LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to develop free GAGome-based tests for multi-cancer early detection in adults asymptomatic for cancer and with no recent history of cancer (Sub-Study 1) and to validate their diagnostic performance in the target population (Sub-Study 2).
LEV87A uses retrospectively collected biospecimens from one or more population-based biobanks representative of the target population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 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 combined free GAGome MCED test
时间窗: Within 365 days after the baseline visit
Indicative of any-type cancer vs. no cancer diagnosis
次要结局
- Sensitivity and specificity of the plasma free GAGome MCED test(Within 365 days after the baseline visit)
- Overall survival (OS) in the case (cancer) arm(From baseline visit until the date of death from any cause, assessed up to 15 years)
- Sensitivity and specificity of the urine free GAGome MCED test(Within 365 days after the baseline visit)
- Accuracy to the "putative cancer location" (PCL) model in the case (cancer) arm(Within 365 days after the baseline visit)