ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- QoL
研究概览
简要总结
Anal cancer is a rare disease, but the incidence is rising. About 200 patients will get this type of cancer yearly in Sweden. Curative treatment includes chemotherapy and radiotherapy. The prognosis is good, but some patients will have recurrent or persistent disease after concluded chemo-radiotherapy and will then be offered salvage surgery. Some patients develop distant metastases that can be treated with good results.
The aim of this study is to identify and describe functional outcome in patients diagnosed with anal cancer. We will study patients from diagnosis, try to identify early toxicity to treatment and then identify long-term morbidity.
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
- •Anal squamous carcinoma diagnosed within the last 2 months
排除标准
- •No informed consent
结局指标
主要结局
QoL
时间窗: 3 months after diagnosis
Health related QoL at
Urinary function
时间窗: 3 months after diagnosis
Evaluate urinary dysfunction
Toxicity related to treatment
时间窗: 3 months after diagnosis
Number of patients with severe toxicity from the chemoradiotherapy
Sexual function
时间窗: 3 months after diagnosis
Evaluate sexual function
Bowel function
时间窗: 3 months after diagnosis
Evaluate bowelfunction
次要结局
- Bowel function(12 months after diagnosis)
- Sexual function(3 years after diagnosis)
- Bowel funcction(3 years after diagnosis)
- QoL(3 years after diagnosis)
- Urinary function(3 years after diagnosis)
研究者
Eva Angenete
Professor
Sahlgrenska University Hospital, Sweden