NeuroblastomaNCT03686566
Pediatric Solid Tumor Metabolism [A Prospective Study Exploring Metabolism of Solid Tumors in Pediatrics]
An observational study of Neuroblastoma and Sarcoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroblastoma, Sarcoma, Pediatric Cancer
- What is being tested?
- 13C-glucose and No glucose infusion
- Type of treatment
- Injection or infusion
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 26 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children, adolescents and young adults through the age of 26 years old with a suspected malignant extra-cranial solid tumor.
Who may be able to join
- 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
Who cannot join
- Poorly controlled diabetes
- Any other medical condition that prevents administration of glucose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Solid Tumor Metabolism [A Prospective, Single Center Study Exploring Solid Tumor Metabolism of Extra-cranial Tumors in the Pediatric Population]
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.
Read the 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
- Neuroblastoma, Sarcoma, Pediatric Cancer
- Being tested
- 13C-glucose, No glucose infusion
- Medical subject headings
- Neuroblastoma, Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-glucoseDrug
Also called U-C 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
No glucose infusionOther
Only includes standard pre-operation nursing care
| Study group | Role | What they receive |
|---|---|---|
| 13C-glucose infusion | Tumor samples of patients who receive the optional 13C-glucose infusion will be studied using flux analysis and metabolomic profiling. Receives: Drug: 13C-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. Receives: Other: No glucose infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic phenotypes
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)
Measured: 2 years
Compare the metabolic phenotype with the result of histopathological diagnosis and genetic alterations of the specific tumor
We will collect data and information from the patient's medical record including pathologic diagnosis and genetic testing results throughout their treatment
Measured: 2 years
Secondary outcomes (3)
Metabolic evolution of tumors over time
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)
Measured: 2 years
Metabolic change due to chemotherapy
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.
Measured: 2 years
Metabolic phenotypes and outcomes
Assess for correlations between metabolism and patient outcome if applicable
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start16 Nov 2018
- Primary completion2 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Watt, University of Texas Southwestern Medical Center
- Investigators
- Tanya Watt, MD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686566
- Sponsor's protocol ID
- STU 052018-100
- Status last verified
- Feb 2024
- First submitted
- 10 Sep 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2021 Apr 9;2(4):395-410. doi: 10.1016/j.medj.2021.01.002. Epub 2021 Feb 23.
PubMed 33860280
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Solid Tumor Metabolism [A Prospective, Single Center Study Exploring Solid Tumor Metabolism of Extra-cranial Tumors in the Pediatric Population]
- ClinicalTrials.gov ID
- NCT03686566
- Acronym / sponsor ID
- STU 052018-100
- Conditions
- Neuroblastoma, Sarcoma, Pediatric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13C-glucose infusion | – | Drug: 13C-glucoseTumor samples of patients who receive the optional 13C-glucose infusion will be studied using flux analysis and metabolomic profiling. |
| No 13C-glucose infusion | – | Other: No glucose infusionTumor samples of patients who do not choose to receive the optional 13C-glucose infusion will be studied using metabolomic profiling alone. |
Who may qualify
- Ages
- Up to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children, adolescents and young adults through the age of 26 years old with a suspected malignant extra-cranial solid tumor.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Poorly controlled diabetes
- Any other medical condition that prevents administration of glucose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C-glucoseAlso: U-C glucoseIncludes standard pre-operation nursing care, 13C-glucose infusion and finger stick/IV glucose checks and storage of blood sample approximately every 30 minutes | Drug | 13C-glucose infusion |
| No glucose infusionOnly includes standard pre-operation nursing care | Other | No 13C-glucose infusion |
Primary outcome
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
3 secondary outcomes
Metabolic evolution of tumors over time
Time frame: 2 years
Metabolic change due to chemotherapy
Time frame: 2 years
Metabolic phenotypes and outcomes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 33860280Johnston 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. 2021 Apr 9;2(4):395-410. doi: 10.1016/j.medj.2021.01.002. Epub 2021 Feb 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Watt, MD principal investigator
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma and Sarcoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic phenotypes (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03686566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.