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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686566
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : January 5, 2023
Sponsor:
Information provided by (Responsible Party):
Tanya Watt, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Neuroblastoma Sarcoma Pediatric Cancer Drug: 13C-glucose Other: No glucose infusion

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. Metabolic phenotypes and outcomes [ Time Frame: 2 years ]
    Assess for correlations between metabolism and patient outcome if applicable


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Tanya Watt, MD 214-456-6363 tanya.watt@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Tanya Watt, MD    214-456-7000    Tanya.Watt@utsouthwestern.edu   
Sponsors and Collaborators
Tanya Watt
Investigators
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Principal Investigator: Tanya Watt, MD UTSW
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tanya Watt, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03686566    
Other Study ID Numbers: STU 052018-100
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neuroblastoma
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
 Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue