Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Lactate Utilisation in the TCA cycle
研究概览
简要总结
This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.
详细描述
This is a single-centre, correlative study designed to investigate metabolic phenotypes in a longitudinal cohort of patients with melanoma. This study will involve the collection of tissue at the time of surgical excision or biopsy. The key intervention, in a subset of patients, will be to perform peri-operative infusions of a stable isotope, [U13C]Glucose. Patients will be intravenously administered sterile, pyrogen-free 13C-glucose, delivered as an 8g bolus followed by infusion of 4g/hour for 2-3 hours. Blood samples will be obtained to monitor glucose and to analyse enrichment of labelled nutrients by gas-chromatography mass spectrometry (GC-MS). At the time of resection or biopsy, tumour samples will be divided and either immediately frozen in liquid nitrogen or processed to form patient-derived xenografts. Frozen tumour samples will be subsequently processed for: isotope enrichment by GC-MS; global metabolomics by liquid-chromatography mass spectrometry (LC-MS); and genomic analyses. Relevant clinical, histologic and genomic features will also be correlated with metabolic findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Patient has provided written informed consent
- •Male or female aged 18 years or older at written informed consent
- •Presence of a known melanoma lesion requiring surgical excision or biopsy
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing biopsies and receiving a stable isotope infusion (where applicable)
排除标准
- •Patients who meet any of the following criteria will be excluded from receiving a [U-13C]Glucose infusion:
- •Diabetes mellitus
- •Pregnancy or breast feeding
- •Patients unable to comply with study procedures and follow up in the opinion of the investigator
结局指标
主要结局
Lactate Utilisation in the TCA cycle
时间窗: 5 years
In patients receiving a \[U-13C\]Glucose infusion, assess lactate utilisation in the TCA cycle (using the ratio of lactate M+3/3PG M+3 as a surrogate measure)
Glucose Utilisation in the TCA cycle
时间窗: 5 years
In patients receiving a \[U-13C\]Glucose infusion, assess glucose utilisation in the TCA cycle (using the ratio of citrate M+2/pyruvate M+3, a surrogate of the pyruvate dehydrogenase reaction)
次要结局
- Relapse free survival(5 years)
- Overall Survival(5 years)
