Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UMC Utrecht
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Occurence of toxicity (adverse events)
研究概览
简要总结
Objective: 1) To collect information on patient characteristics, short- and long-term clinical and patient-reported outcomes; and 2) to create an infrastructure for efficient, fast, and pragmatic randomized evaluation of new interventions.
Study design: Observational, prospective cohort study, according to the 'TwiCs' design.
Study population: All patients with lung cancer referred to the Department of Pulmonology or the Department of Radiotherapy of the UMC Utrecht.
Main study parameters/endpoints: Clinical parameters (performance status, co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (toxicity, reintervention and survival), and patient-reported outcomes.
详细描述
The prospective U-COLOR cohort (Utrecht COhort for Lung cancer Outcome Reporting and trial inclusion), aims to:
- Gather data on natural disease progression, treatment response, disease recurrence, complications, quality of life and survival of patients with lung cancer;
- Collect a patient group willing to participate in studies;
- Facilitate multiple, parallel randomized controlled trials within the cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years;
- •Radiographic and/or histologic proof of lung cancer;
- •Referred to Department of Pulmonology or the Department of Radiotherapy for treatment.
排除标准
- •Mental disorder or cognitive dysfunction that hinders the patient's ability to understand the informed consent procedure and/or study details;
- •Patients with severe psychiatric disorders;
- •Inability to understand the Dutch language.
结局指标
主要结局
Occurence of toxicity (adverse events)
时间窗: Up to 10 years after treatment
Grade ≥3 side effects occurring during or up to 3 months after radiotherapy will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). For 'dysphagia' and 'pneumonitis' endpoints, also grade 2 toxicity will be scored.
Survival
时间窗: Up to 10 years after treatment
Date of last follow-up, date of local progression, date of distant progression, location of distant progression. Overall survival (Survival of participating patients will be recorded using the follow up questionnaires \[returned by family members\] or are derived from the Statistic Netherlands Database \[in Dutch: Centraal Bureau voor de Statistiek, CBS\] and Dutch Cancer Registry \[in Dutch: Integraal Kankercentrum Nederland, IKNL\]).
Change in Health-related Quality of Life
时间窗: Up to 10 years after treatment
Assesment of Health-related quality of life in lung cancer patients undergoing treatment
Readmission
时间窗: Up to 10 years after treatment
Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.
次要结局
未报告次要终点