跳至主要内容
临床试验/NCT05570227
NCT05570227招募中不适用

Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma

Peter MacCallum Cancer Centre, Australia2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年6月27日最近更新:
适应症

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

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)

研究者

发起方
Peter MacCallum Cancer Centre, Australia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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