ABCSG TR Spotlight: Validation of an Artificial Intelligence-based Prognostic Assay in ER+/HER2- Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Time to distant recurrence
研究概览
简要总结
This retrospective observational study evaluates the prognostic performance of a locked Artificial Intelligence (AI)-based assay in patients with Estrogen Receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative early breast cancer (EBC) from Austrian Breast & Colorectal Cancer Study Group (ABCSG)-8, with extended follow-up from ABCSG-16 where available. ABCSG will provide digitized hematoxylin and eosin (H&E) slides and required baseline clinicopathologic variables to Spotlight Medical without outcome data for blinded assay inference. ABCSG will then perform the prespecified statistical analyses linking assay outputs to clinical outcomes.
详细描述
This is an independent, external, blinded, retrospective validation study of a locked AI-based prognostic assay in ER-positive/HER2-negative EBC.
The source population consists of eligible patients from ABCSG-8 with available archived tumor material suitable for H&E slide digitization, with extended follow-up from ABCSG-16 where available. Primary analyses will be conducted in patients with slides that pass prespecified quality control and with required baseline clinicopathologic variables available or derivable according to the prespecified statistical analysis plan.
The assay generates a continuous prognostic score and predefined risk categories using one digitized H&E-stained surgical resection slide together with routine baseline clinicopathologic variables. Spotlight Medical will generate assay predictions while blinded to clinical outcomes. ABCSG will conduct the statistical analyses according to a prespecified protocol and statistical analysis plan.
The primary objective is validation of the association of the assay with time to distant recurrence. Secondary objectives are validation of the association of the assay with disease-free survival and overall survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients enrolled in ABCSG-8
- •Postmenopausal patients with ER-positive/HER2-negative early invasive breast cancer
- •Available archived primary tumor material suitable for H&E slide digitization
- •Available required baseline clinicopathologic variables or variables derivable according to the prespecified statistical analysis plan
- •Patients with permission for inclusion in this retrospective translational research study
排除标准
- •No suitable archived primary tumor material for H&E slide digitization
- •Missing required baseline clinicopathologic variables not recoverable according to the prespecified statistical analysis plan
- •No analyzable follow-up for the endpoint of interest
研究组 & 干预措施
Eligible ABCSG-8 cohort
Eligible patients from ABCSG-8 within the ER-positive/HER2-negative validation population, with available tumor material for H&E digitization and required baseline clinicopathologic variables, and with extended clinical follow-up from ABCSG-16 where available.
干预措施: Locked AI-based prognostic assay (Diagnostic Test)
结局指标
主要结局
Time to distant recurrence
时间窗: From ABCSG-8 randomization to distant recurrence, assessed up to 15 years.
Association of the continuous assay score and predefined risk categories with time to distant recurrence.
次要结局
- Disease-free survival(From ABCSG-8 randomization to first disease-free survival event, assessed up to 15 years.)
- Overall survival(From ABCSG-8 randomization to death from any cause, assessed up to 15 years.)