CAUSAL: Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- Impact of treatment on adverse oncologic outcomes
研究概览
简要总结
This study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time.
详细描述
- To evaluate the incidence and prevalence and the impact of disease, treatment, sociodemographic and lifestyle contributors on adverse oncologic outcomes (lack of response, recurrence) and non- oncologic outcomes (physical and psychosocial function, financial toxicity, short and long-term organ toxicity) and mortality in the cohort.
- To evaluate the role of drug metabolism and DNA repair genes via functional polymorphisms, known toxicity associated polymorphisms and genetically predicted gene expression levels, as well as polygenic risk scores, on treatment efficacy, cancer therapy-induced normal tissue toxicity and mortality.
- To identify genomic drivers of sarcoma and to use this information to develop personalized liquid biopsy assays for monitoring treatment response, recurrence, and minimal residual disease (MRD) and mortality.
- Evaluate family functioning, psychosocial wellbeing, and financial toxicity.
OUTLINE: This is an observational study.
Patients monitor physical activity, sedentary behavior, heart rate and sleep wearing a FitBit device, undergo blood urine, stool and/or saliva sample collection, complete surveys and have medical records reviewed throughout study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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
Impact of treatment on adverse oncologic outcomes
时间窗: Approximately six years
Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)
Impact of lifestyle contributors on adverse oncologic outcomes
时间窗: Approximately six years
Patient-reported outcome
Impact of disease on adverse oncologic outcomes
时间窗: Approximately six years
Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)
Impact of sociodemographic contributors on adverse oncologic outcomes
时间窗: Approximately six years
Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
次要结局
未报告次要终点
研究者
Debra Friedman
Professor of Pediatrics (Pediatric Hematology and Oncology)
Vanderbilt-Ingram Cancer Center
