Identification of Metabolic Phenotypes Associated With Melanoma Metastasis
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT06400550
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.
- Subjects of all races and ethnic origins over age 18.
- Not a surgical candidate
- Poorly controlled diabetes
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glucose Utilisation in the TCA cycle 5 years In 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 Outcome Measures
Name Time Method Relapse free survival 5 years Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first
Overall Survival 5 years Measured as the time of surgery until death from any cause
Development of Lymph Node or Distant Metastasis 5 years Defined as yes/no for each type of metastasis
Trial Locations
- Locations (1)
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States