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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 : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Tanya Watt, University of Texas Southwestern Medical Center

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 Phase
Neuroblastoma Sarcoma Pediatric Cancer Drug: 13C-glucose Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
13C-glucose infusion
All participants consented to the study will receive the 13C-glucose infusion.
Drug: 13C-glucose
13C-glucose, glucose with every carbon labeled, is a naturally occurring, stable isotope of carbon and is not radioactive. 13C-glucose in sterile water will be mixed in the investigational pharmacy and brought to the patient area on the day of surgery. 13C-glucose will be administered over 3 hours with the total dose and volume based on patient weight. The duration of infusion may be prolonged if more time is required to remove the tumor sample during surgery. We will obtain serum glucose levels and blood samples during the infusion. When the tumor is biopsied, we will also obtain a piece of the tumor for research purposes. We will analyze the metabolism of the labeled glucose with use of mass spectrometry and metabolomics.
Other Name: U-C glucose




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



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

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
Contact: Kendra Johnston, MD 214-456-7000 kendra.johnston@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Kendra Johnston, MD    214-456-7000    kendra.johnston@utsouthwestern.edu   
Contact: Tanya Watt, MD    214-456-7000      
Sponsors and Collaborators
Tanya Watt
Investigators
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Principal Investigator: Tanya Watt, MD UTSW

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Responsible Party: Tanya Watt, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03686566     History of Changes
Other Study ID Numbers: STU 052018-100
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
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