Pediatric Solid Tumor Metabolism [A Prospective, Single Center Study Exploring Solid Tumor Metabolism of Extra-cranial Tumors in the Pediatric Population]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Metabolic phenotypes
研究概览
简要总结
To explore metabolic phenotypes of children with extra-cranial solid tumors and compare these with their histopathological and genetic alterations to discover potential novel biomarkers and therapeutic targets to improve outcomes in children with high risk disease.
详细描述
The principal objective of this study is the metabolic characterization of pediatric solid tumors, with a particular focus on neuroblastoma (NBL) and fusion positive sarcoma (FPS), which will allow the detection of tumor specific metabolic alterations that can be exploited with the aim of developing novel therapeutic strategies and biomarkers.
Cellular metabolism studies provide insight, in a complementary way to genomics, into processes acting downstream from oncogenes and oncogenic fusion proteins, and such insight may point toward previously unrecognized therapeutic targets or onco-metabolites that are traceable as robust biomarkers for response. The investigator's new approach to use an in-vivo comprehensive analysis of metabolic reprograming in FPS/NBL has never been performed in childhood FPS/NBL and will complement genomics studies for these cancers. For this study, the investigators plan to obtain tumor samples at time of surgical biopsy/resection and study their metabolic signatures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suspected malignancy
- •Age ≤ 26 years and being cared for at Children's Medical Center
- •Ability to undergo standard of care diagnostic procedure, including biopsy or resection of the tumor, in the OR or IR at CMC
排除标准
- •Poorly controlled diabetes
- •Any other medical condition that prevents administration of glucose
研究组 & 干预措施
13C-glucose infusion
Tumor samples of patients who receive the optional 13C-glucose infusion will be studied using flux analysis and metabolomic profiling.
干预措施: 13C-glucose (Drug)
No 13C-glucose infusion
Tumor samples of patients who do not choose to receive the optional 13C-glucose infusion will be studied using metabolomic profiling alone.
干预措施: No glucose infusion (Other)
结局指标
主要结局
Metabolic phenotypes
时间窗: 2 years
Upon collection of tumor samples, they will be processed and analyzed with mass spectrometry to learn how the tumor processes the labeled glucose by assessing enrichment of metabolites to identify the active metabolic pathways in each tumor (metabolic phenotype)
Compare the metabolic phenotype with the result of histopathological diagnosis and genetic alterations of the specific tumor
时间窗: 2 years
We will collect data and information from the patient's medical record including pathologic diagnosis and genetic testing results throughout their treatment
次要结局
- Metabolic evolution of tumors over time(2 years)
- Metabolic change due to chemotherapy(2 years)
- Metabolic phenotypes and outcomes(2 years)
研究者
Tanya Watt
Assistant Professor of Pediatrics
University of Texas Southwestern Medical Center