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 : January 5, 2023
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Tracking Information | |||||||
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First Submitted Date | September 10, 2018 | ||||||
First Posted Date | September 27, 2018 | ||||||
Last Update Posted Date | January 5, 2023 | ||||||
Actual Study Start Date | November 16, 2018 | ||||||
Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | 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] | ||||||
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. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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. | ||||||
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Publications * | 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 (N Y). 2021 Apr 9;2(4):395-410. doi: 10.1016/j.medj.2021.01.002. Epub 2021 Feb 23. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
100 | ||||||
Original Estimated Enrollment |
40 | ||||||
Estimated Study Completion Date | November 2024 | ||||||
Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 26 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts |
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Listed Location Countries | United States | ||||||
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Administrative Information | |||||||
NCT Number | NCT03686566 | ||||||
Other Study ID Numbers | STU 052018-100 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Tanya Watt, University of Texas Southwestern Medical Center | ||||||
Original Responsible Party | University of Texas Southwestern Medical Center | ||||||
Current Study Sponsor | Tanya Watt | ||||||
Original Study Sponsor | University of Texas Southwestern Medical Center | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | University of Texas Southwestern Medical Center | ||||||
Verification Date | January 2023 |