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Identification of Metabolic Phenotypes Associated With Melanoma Metastasis

Identification of Metabolic Phenotypes Associated With Melanoma Metastasis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06400550
Enrollment
400
Registered
2024-05-06
Start date
2018-08-01
Completion date
2028-08-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Brief summary

The goal of this study is to observe metabolic features associated with human melanoma tumors.

Detailed description

This is a single center, correlative study designed to assess metabolic features of melanoma tumors in patients. The study will involve the collection of melanoma tissue at the time of surgical biopsy or excision. All samples will be assessed by mass spectrometry for metabolomic analysis. A subset of patients will have received \[U-13C\]glucose infusions which will be utilized for isotope tracing metabolic analysis. Relevant clinical data (eg survival, metastasis) will be correlated with metabolic findings.

Interventions

None listed

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision. * Subjects of all races and ethnic origins over age 18.

Exclusion criteria

* Not a surgical candidate * Poorly controlled diabetes

Design outcomes

Primary

MeasureTime frameDescription
Glucose Utilisation in the TCA cycle5 yearsIn patients receiving a \[U-13C\]Glucose infusion, assess glucose utilization in the TCA cycle by melanoma tumors (defined as fractional enrichment of 13C-label in TCA metabolites)

Secondary

MeasureTime frameDescription
Relapse free survival5 yearsDefined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first
Overall Survival5 yearsMeasured as the time of surgery until death from any cause
Development of Lymph Node or Distant Metastasis5 yearsDefined as yes/no for each type of metastasis

Countries

United States

Contacts

CONTACTAleuna Lee
aleuna.lee@utsouthwestern.edu2146458968
PRINCIPAL_INVESTIGATORJennifer Gill, MD, PhD

University of Texas Southwestern Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026