Clinical trial NCT03686566: Pediatric Solid Tumor Metabolism [A Prospective Study Exploring Metabolism of Solid Tumors in Pediatrics]
Official title: Pediatric Solid Tumor Metabolism [A Prospective, Single Center Study Exploring Solid Tumor Metabolism of Extra-cranial Tumors in the Pediatric Population]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Sarcoma
Pediatric Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 84
Sex: ALL
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, adolescents and young adults through the age of 26 years old with a suspected malignant extra-cranial solid tumor.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Poorly controlled diabetes
* Any other medical condition that prevents administration of glucose

Primary outcomes:
measure: Metabolic phenotypes
timeFrame: 2 years
measure: Compare the metabolic phenotype with the result of histopathological diagnosis and genetic alterations of the specific tumor
timeFrame: 2 years
Secondary outcomes:
measure: Metabolic evolution of tumors over time
timeFrame: 2 years
measure: Metabolic change due to chemotherapy
timeFrame: 2 years
measure: Metabolic phenotypes and outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: UTSW
name: Tanya Watt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnston K, Pachnis P, Tasdogan A, Faubert B, Zacharias LG, Vu HS, Rodgers-Augustyniak L, Johnson A, Huang F, Ricciardo S, Zhao Z, Mathews TP, Watt T, Leavey P, DeBerardinis RJ. Isotope tracing reveals glycolysis and oxidative metabolism in childhood tumors of multiple histologies. Med. 2021 Apr 9;2(4):395-410. doi: 10.1016/j.medj.2021.01.002. Epub 2021 Feb 23.