Trials / Completed
CompletedNCT03686566
Pediatric Solid Tumor Metabolism [A Prospective Study Exploring Metabolism of Solid Tumors in Pediatrics]
Pediatric Solid Tumor Metabolism [A Prospective, Single Center Study Exploring Solid Tumor Metabolism of Extra-cranial Tumors in the Pediatric Population]
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 84 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 26 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-11-16
- Primary completion
- 2024-01-02
- Completion
- 2024-01-26
- First posted
- 2018-09-27
- Last updated
- 2024-02-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03686566. Inclusion in this directory is not an endorsement.