Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Percentage of head and neck cancer detected with a blood sample
研究概览
简要总结
This study investigates if head and neck squamous cell carcinoma can be tracked with cell-free tumor DNA, RNA or HPV-DNA, in blood samples from patients referred with suspicion of cancer, and if it can be used in detecting recurrence in patients already diagnosed and treated for head and neck squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Patients 18 years old or older
- •Suspicion of head and neck cancer
排除标准
- •Diagnosed with cancer within the last 3 years ( apart from basal cell carcinoma)
- •Diagnosed with an inflammatory or haematological disease after the age of 18
- •Received chemotherapy or immunosuppressive treatment within the last 3 years
- •Underwent a FNA ( fine-needle aspiration biopsy) or a biopsy from the head and neck region within 1 week.
结局指标
主要结局
Percentage of head and neck cancer detected with a blood sample
时间窗: 0 months
The primary outcome is to measure the percentage of head and neck squamous cell carcinomas that can be detected using a liquid biopsy (blood sample)
Percentage of head and neck cancer recurrence detected with a blood sample
时间窗: 36 months
The primary outcome is to measure the percentage of recurrence in head and neck cancer patients through serial monitoring with liquid biopsies (blood sample)
次要结局
未报告次要终点
研究者
Christian von Buchwald
Clinical Professor
Rigshospitalet, Denmark