ANCABio - a Study Regarding Tumour Microenvironment and the Predictive Capability of Biopsies from Anal Cancer in Predicting Response and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- ctDNA
研究概览
简要总结
The aim of this study is to improve the understanding for the tumour biology in relation to treatment response in patients with anal cancer by examining:
- The tumour microenvironment
- The localisation of and cellular interactions between the tumour and immune cells
- The gene and protein expression by cells present in the tumour and surrounding tissue.
详细描述
All adult patients with anal cancer presenting within the Sahlgrenska University Hospital catchment area or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. The patients that are newly diagnosed or that have a suspected recurrence will be offered to enter the study with biopsies as well as blood samples during the diagnostic examination that is performed under anaesthesia. Biopsies will then be taken during follow-up exams if applicable. Biopsies will also be taken during surgery if that is scheduled and in cases where surgery is not necessary biopsies will be taken if the patient undergoes examinations under anaesthesia after treatment cessation.
If it is not possible to take biopsies prior treatment blood samples will still be drawn.
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
- •Newly diagnosed or recurrent anal cancer
排除标准
- •No diagnosis of anal cancer, contraindication to biopsies and blood samples
结局指标
主要结局
ctDNA
时间窗: 2024-2029
circulating tumour DNA
Tumour micro environment
时间窗: 2024-2029
Evaluation of immuncell infiltrates in the tumour micro environment
次要结局
未报告次要终点
研究者
Eva Angenete
Professor
Sahlgrenska University Hospital