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

Sarcoma Clinical Trial

Official title:

Pediatric Solid Tumor Metabolism [A Prospective, Single Center Study Exploring Solid Tumor Metabolism of Extra-cranial Tumors in the Pediatric Population]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686566
• Other study ID #: STU 052018-100
• Status: Completed
• Start date: November 16, 2018
• Est. completion date: January 26, 2024

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 26, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroblastoma
• Pediatric Cancer
• Sarcoma

Intervention

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

Other:
• No glucose infusion
Only includes standard pre-operation nursing care

Locations

Country	Name	City	State
United States	UT Southwestern	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Metabolic evolution of tumors over time	Compare tumor metabolism at different points in therapy (diagnosis, metastasis, recurrence) if the family consents to further studies as their child's condition progresses. Will compare high risk samples to low risk samples within a diagnosis (IE: high risk neuroblastoma vs low risk neuroblastoma)	2 years
Secondary	Metabolic change due to chemotherapy	Compare tumor metabolism at different points in therapy (before vs after chemotherapy is given) if the family consents to further studies as their child's condition progresses. For example, tumor sample at time of neuroblastoma biopsy to resection a few months later prior to bone marrow transplantation.	2 years
Secondary	Metabolic phenotypes and outcomes	Assess for correlations between metabolism and patient outcome if applicable	2 years