Influence of Nutrition and SarcoPenia on Esophageal Cancer ouTcomes (INSPECT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,717
- 试验地点
- 1
- 主要终点
- Longitudinal variation in body composition
研究概览
简要总结
Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study.
详细描述
Patients undergoing curative treatment for esophageal cancer will be recruited at the time of routine clinical assessment shortly following initial diagnosis and will undergo clinical and radiological evaluation at two study time points: (1) staging investigation (e.g. laparoscopy or endoscopy) and (2) definitive surgical resection. Study time points have been judiciously chosen to coincide with interventions that form part of patient's routine clinical care. It is intended that sampling will occur on the day of each intervention/surgery following a routine period of fasting.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the following characteristics will be eligible for inclusion in this study:
- •Age 18-90 years
- •Newly diagnosed (prior to treatment) with esophageal and/or gastroesophageal junctional cancer (adeno- or squamous cell carcinoma)
- •Planning to undergo curative treatment, including surgical resection with or without neoadjuvant therapy
排除标准
- •Patients with the following characteristics will not be eligible for inclusion in this study:
- •Pregnant females
- •Without malignant esophageal disease
- •Inability or unwillingness to provided informed written consent
结局指标
主要结局
Longitudinal variation in body composition
时间窗: Approximately 1 year
Establish the effect of patient and disease-specific factors on body composition in a global cohort of patients undergoing esophagectomy for cancer
次要结局
- Patient and disease-specific factors(Approximately 1 year)