Feasibility of Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- The feasibility of the pedsETB developing therapeutic strategies
研究概览
简要总结
To evaluate the ability of a multidisciplinary and multisite group, the Pediatric Evolutionary Tumor Board (pedsETB), to develop additional therapeutic strategies in patients without curative options or with suboptimal outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be considered likely incurable given the standard of care. This is inclusive of patients newly diagnosed, relapsed or in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but unlikely curative options for care.
- •The site investigator will make this determination based on their experience.
- •Participant must have an age-appropriate performance status: Karnofsky 50 or more for patients 16 years of age or older OR Lansky score of 50 or more for patients less than16 years of age.
- •Participant and/or parents or legal guardian and primary oncologist must be willing to consider the therapeutic strategies recommended by the pedsETB.
- •Participant must be willing to be followed over time and allow collection of clinical data including scans, available blood and lab samples, and optional pedsETB serial blood sampling.
- •All Participants and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.
排除标准
- •Participants without known therapies to reliably induce a response are excluded from pedsETB and should seek clinical trials.
研究组 & 干预措施
Participants Reviewed by ETB
Participants clinical history, available therapeutic options, and outcome expectations will be presented to the Evolutionary Tumor Board (ETB) along with images and pathology. Strategies and models will be presented regarding additional evolutionary ideas that can be applied.
These ideas will be characterized (e.g. first strike-second strike, adaptive, novel sequential therapy, novel combination, novel dosing schedule, etc.).
干预措施: Peds Evolutionary Tumor Board (pedsETB) (Other)
结局指标
主要结局
The feasibility of the pedsETB developing therapeutic strategies
时间窗: Baseline to up to 60 months from end of therapy
The investigators will measure the ability of a multidisciplinary group, the pedsETB, to develop additional therapeutic strategies in patients without curative options. The investigators plan to enroll 35 patients on the study. The primary objective will be successfully met if the pedsETB can develop an evolutionary based therapeutic strategy that differs from the oncologist's opinion prior to presentation for at least 80%, or 28 of these patients.
次要结局
未报告次要终点