Prospective Study Evaluating ctDNA as a Biomarker for Treatment Response in Head and Neck Squamous Cell Carcinoma'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The number of patients in which ctDNA measurement (in amplifiable copies per millilitre blood and saliva) accurately predicts treatment outcome within 2 years after treatment, in terms of FFP.
研究概览
简要总结
Tumours continually shed DNA into the circulation, where it can be accessed. This circulating tumour DNA (ctDNA) directly reflects tumour burden and has great potential to be a sensitive biomarker for treatment recurrence. These "liquid biopsies" could give a more real-time picture of the genomic status and evolution of a tumour and can be easily assessed for measurement of different biomarkers. However, in head and neck squamous cell carcinoma (HNSCC) patients treated with primary curative radiotherapy, data regarding ctDNA kinetics and its correlation with outcome are scarce. A new or additional tool for response evaluation next to or instead of conventional imaging after treatment would be beneficial to detect recurrences in an earlier stage, thereby increasing the chances of success of salvage therapy. More importantly, an early response parameter during treatment could help to identify patients that have a good treatment response and might benefit from treatment adaptation. With this study, we aim to reveal ctDNA as an effective tool for future dose (de)-escalation trials in HNSCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •≥ 18 years of age
- •Stage II-IV carcinoma of the larynx, hypopharynx, oral cavity or HPV negative oropharynx or stage II-III HPV positive oropharyngeal carcinoma, histologically confirmed according to the American Joint Committee on Cancer (AJCC) staging manual 8th edition
- •Indication for primary curative radiotherapy with or without concurrent radio sensitizer
- •WHO performance status 0-2
- •Signed written IC
排除标准
- •Metastatic disease
- •Radiotherapy with palliative intent
- •Diagnosis of any other malignancy within 5 years prior to start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g. surgery, radiation or castration).
结局指标
主要结局
The number of patients in which ctDNA measurement (in amplifiable copies per millilitre blood and saliva) accurately predicts treatment outcome within 2 years after treatment, in terms of FFP.
时间窗: 2 years
ctDNA biomarker
次要结局
- Levels of ctDNA at the time of corresponding conventional imaging in relation to disease occurrence.(3 years)
- The number of traceable mutations found in blood / saliva in comparison with mutations found in tissue biopsies.(3 years)
- Levels of ctDNA in blood compared to saliva at the same time points.(At study completion, after 3 years)
- The tumours' genomic status and epigenetic evolution over time under pressure of radiotherapy, in terms of number of different detectable mutations at all specified time points.(3 years)
- CtDNA kinetics (clearance time, drop below a certain level, complete absence, etc.) during radiotherapy as a predictor for disease recurrence within 2 years after treatment, in terms of FFP.(2 years)
- Levels of ctDNA before treatment compared to other clinical/biological parameters in the prediction of treatment response.(3 years)