Exploratory Study of Early Biomarkers Allowing Dynamic Assessment of Response to Treatment in Cancers of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The level of circulating tumour DNA pre-treatment will be descriptively compared to the levels detected at subsequent time points
研究概览
简要总结
DART is an exploratory molecular analysis study to assess potential early biomarkers of treatment response in squamous cell carcinoma of the head and neck (HNSCC)
详细描述
If cancer that starts in the head or neck is not suitable for surgery or radiotherapy, then it cannot be cured. Unfortunately, people in this situation have a short life expectancy, with half dying within 12 months. There are treatments available that have helped people in this situation live longer, most recently drugs that stimulate the body's own immune system to attack the cancer, known as 'immunotherapy'. Some people do very well on these treatments, living many years, while the same treatments offer no benefit to others - it is not known why. This study is looking at collecting samples of a person's cancer, along with other body fluids, particularly blood and saliva, to see if the investigators can track changes in blood and saliva that happen in a person's cancer while they are receiving treatment. Additionally, samples of the cancer will be used to see if they can be grown in the laboratory to test growth behaviour and how well different treatments work.
The investigators will ask people being treated for incurable cancer that started in the head and neck for permission to collect their blood and saliva, along with samples of their cancer tissue, while they are having treatment. Nearly all patients will require a sample of their cancer tissue taken with a needle (a 'biopsy') anyway, and tissue samples can be taken as part of this process. Similarly, the safe administration of cancer drugs requires blood tests before every course of treatment, and research bloods can be taken from the same blood draw. A small number of people will be asked whether they give their permission for an extra biopsy of their cancer to allow further comparisons in the laboratory.
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 or older
- •Patients with histologically confirmed cancer of the head and neck with evidence of recurrent or locally advanced cancer not suitable for treatment with curative intent, or metastatic disease.
- •Receiving immunotherapy
- •Ability to give informed consent for biological sample collection.
排除标准
- •Unable to undergo serial sample collection
- •Pregnancy
结局指标
主要结局
The level of circulating tumour DNA pre-treatment will be descriptively compared to the levels detected at subsequent time points
时间窗: Through study completion, expected duration of 5 years
次要结局
- To correlate assays with clinicopathological data.(Through study completion, expected duration of 5 years)
- To collect longitudinal biological samples, including blood, saliva and tissue, for molecular profiling(Through study completion, expected duration of 5 years)
- To collect tumour tissue to facilitate molecular analysis of recurrent or metastatic cancers of the head and neck.(Through study completion, expected duration of 5 years)
- Retrieval and analysis of archival primary tissue blocks for comparison with metastatic tumour sites.(Through study completion, expected duration of 5 years)
- To isolate live tumour and immune cells for studies of therapy resistance and biology in cancers of the head and neck.(Through study completion, expected duration of 5 years)