Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- To identify subjects with RNA signatures who may be eligible for clinical trial enrollment
研究概览
简要总结
The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.
详细描述
The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.
A parallel study, StrataPATH™ (STR-004-001), has been developed to support therapeutic hypotheses. Participants may be consented and screened for enrollment separately into StrataPATH with an eligible matching biomarker/drug treatment cohort upon positive identification of a relevant expression signature. Treatment effectiveness of antibody drug conjugates and other targeted therapies will be evaluated in these molecularly defined cohorts.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Must be ≥18 years of age,
- •Participant must have pathologically confirmed advanced, metastatic, or recurrent solid tumor,
- •Measurable disease,
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2,
- •Participant must meet at least 1 of the following:
- •Is/has not adequately responded to standard therapy, or
- •For whom no life-extending standard therapy exists, or
- •Who decline standard therapy, or
- •In the opinion of the investigator, is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy
- •Adequate cardiac, bone marrow, organ function & laboratory parameters as determined by the treating physician for potential participation in a clinical trial,
- •Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing
排除标准
- •Females who are pregnant or nursing,
- •History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 4 months of enrollment,
- •Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation in a clinical trial undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.
结局指标
主要结局
To identify subjects with RNA signatures who may be eligible for clinical trial enrollment
时间窗: 5 years
The percentage of participants identified as eligible for therapeutic clinical trials.
次要结局
未报告次要终点