Pediatric Solid Tumor Metabolism [A Prospective Study Exploring Metabolism of Solid Tumors in Pediatrics]

NCT03686566 | Completed

• 1 other identifier: STU 052018-100
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma; Sarcoma; Pediatric Cancer

Outcome Measures

Primary Outcomes (2)

• Metabolic phenotypes

  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)

  2 years

• Compare the metabolic phenotype with the result of histopathological diagnosis and genetic alterations of the specific tumor

  We will collect data and information from the patient's medical record including pathologic diagnosis and genetic testing results throughout their treatment

  2 years

Secondary Outcomes (3)

• Metabolic evolution of tumors over time

  2 years

• Metabolic change due to chemotherapy

  2 years

• Metabolic phenotypes and outcomes

  2 years

Study Arms (2)

13C-glucose infusion

Tumor samples of patients who receive the optional 13C-glucose infusion will be studied using flux analysis and metabolomic profiling.

Drug: 13C-glucose

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.

Other: No glucose infusion

Interventions

13C-glucose DRUG

Includes standard pre-operation nursing care, 13C-glucose infusion and finger stick/IV glucose checks and storage of blood sample approximately every 30 minutes

Also known as: U-C glucose

13C-glucose infusion

No glucose infusion OTHER

Only includes standard pre-operation nursing care

No 13C-glucose infusion

Eligibility Criteria

• Age: Up to 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 33860280 DERIVED

MeSH Terms

Conditions

Neuroblastoma; Sarcoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue

Study Officials

• Tanya Watt, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 27, 2018
• Study Start: November 16, 2018
• Primary Completion: January 2, 2024
• Study Completion: January 26, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)