Registration Study on Bone and Soft Tissue Sarcoma - An Observational Cohort Study -
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
The prospective and retrospective data collection on bone and soft tissue sarcoma is an observational cohort study aimed to collect clinical data and patient reported outcomes of all patients who have been diagnosed with bone or soft tissue sarcoma in the Netherlands. All patients diagnosed with bone or soft tissue sarcoma who are treated, planned for treatment or currently being treated, will be asked to participate in this project.
详细描述
The main objectives of this project are:
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To improve the knowledge and therefore the treatment care, in patients with bone or soft tissue sarcoma in the Netherlands
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To start an observational cohort study of bone and soft tissue sarcoma patients from their primary diagnosis until death
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To prospectively and retrospectively collect data on medical history, co-morbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, functional outcome, cosmetic outcome, hospital stays and interventions.
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To collect data on health related quality of life and work ability, to collect data on patient reported outcomes measures.
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To create a continuous basis for a large variety of research purposes including:
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Prognostic and predictive research
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Health care policies and cost-effectiveness studies
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours
排除标准
- •Altered mental status that would prohibit the understanding of and giving of informed consent
结局指标
主要结局
Progression free survival
时间窗: up to 10 years
PFS
次要结局
- grade 3/4 serious adverse events(up to 5 years)
- Overall survival(up to 10 years)
- Disease free survival(up to 10 years)
- Health related quality of life(up to 5 years)