Pediatric Solid Tumor Metabolism [A Prospective Study Exploring Metabolism of Solid Tumors in Pediatrics]
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|ClinicalTrials.gov Identifier: NCT03686566|
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : August 6, 2021
|Condition or disease||Intervention/treatment|
|Neuroblastoma Sarcoma Pediatric Cancer||Drug: 13C-glucose Other: No glucose infusion|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Pediatric Solid Tumor Metabolism [A Prospective, Single Center Study Exploring Solid Tumor Metabolism of Extra-cranial Tumors in the Pediatric Population]|
|Actual Study Start Date :||November 16, 2018|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Tumor samples of patients who receive the optional 13C-glucose infusion will be studied using flux analysis and metabolomic profiling.
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 Name: U-C 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
Only includes standard pre-operation nursing care
- Metabolic phenotypes [ Time Frame: 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 [ Time Frame: 2 years ]We will collect data and information from the patient's medical record including pathologic diagnosis and genetic testing results throughout their treatment
- Metabolic evolution of tumors over time [ Time Frame: 2 years ]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)
- Metabolic change due to chemotherapy [ Time Frame: 2 years ]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.
- Metabolic phenotypes and outcomes [ Time Frame: 2 years ]Assess for correlations between metabolism and patient outcome if applicable
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686566
|Contact: Tanya Watt, MDemail@example.com|
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Contact: Tanya Watt, MD 214-456-7000 Tanya.Watt@utsouthwestern.edu|
|Principal Investigator:||Tanya Watt, MD||UTSW|