SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To measure the frequency of acquired (somatic) mutations
研究概览
简要总结
Recently technology has been developed at the Wellcome Sanger Institute to allow clusters of cells with mutations to be detected in normal and diseased tissues. The researchers wish to determine how the number and nature of these mutant cell clusters change in response to treatments given to cancer patients (such as chemotherapy, radiotherapy, immunotherapy, and drugs targeted at specific mutations in tumours). As such the researchers wish to collect research samples of blood, cheek cells (via swabs) and urine from adult cancer patients receiving the above-mentioned treatments as part of their standard care. The researchers also wish to access any leftover tissue following surgery that is undertaken as part of these patient's treatment.
详细描述
Disease and tissue aging are thought to be influenced by genetic changes, or mutations, acquired throughout life. These mutations provide clues regarding the genetic damage that occurred through the lifetime of the patient, and include mutations caused by environmental factors such as ultraviolet light from sunlight or tobacco smoke affecting the skin or internal tissues, respectively. Other mutations may occur due to errors in copying the genome as cells divide. Once a cell has acquired a mutation, the cell's daughters may inherit it. Eventually clusters of cells carrying the same mutation may form within tissues. If the mutations alter cell behaviour this may impact how cells behave and influence how a whole tissue functions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Due to commence systemic treatment for histologically confirmed cancer at a - participating site
- •Age over 18 years
- •Able to give informed consent.
- •Able to give urine, blood and cheek swab samples on two occasions.
- •Likely to complete 3 months of treatment
排除标准
- •Anyone outside of the inclusion criteria plus individuals who Lack the capacity to provide informed consent and those who do not have a good command of the English language.
- •Any participant who is known to have Hep B, Hep C or HIV
结局指标
主要结局
To measure the frequency of acquired (somatic) mutations
时间窗: 5 years
The study will measure the frequency, size and nature of acquired (somatic) mutations in clusters of cells in normal blood, urinary tract and oral cells changes after cancer treatment.
To measure the size of acquired (somatic) mutations
时间窗: 5 years
The study will measure the size of acquired (somatic) mutations in clusters of cells in normal blood, urinary tract and oral cells changes after cancer treatment.
次要结局
- To understand the nature of acquired (somatic) mutations(5 years)