跳至主要内容
临床试验/NCT06482957
NCT06482957招募中不适用

CAUSAL: Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan

Vanderbilt-Ingram Cancer Center1 个研究点 分布在 1 个国家目标入组 2,100 人开始时间: 2022年4月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Debra Friedman

Professor of Pediatrics (Pediatric Hematology and Oncology)

Vanderbilt-Ingram Cancer Center

研究点 (1)

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