Identification of Metabolic Phenotypes Associated With Melanoma Metastasis

Melanoma (Skin) Clinical Trial

Official title:

Identification of Metabolic Phenotypes Associated With Melanoma Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400550
• Other study ID #: STU 052018-031
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: August 1, 2028

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Aleuna Lee
• Phone: 2146458968
• Email: aleuna.lee[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tumor Metabolomic and Lipidomic Profiling	Abundance of metabolites and lipid species, quantified by liquid chromatography mass spectrometry	5 years
Primary	Glucose Utilisation in the TCA cycle	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)	5 years
Secondary	Relapse free survival	Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first	5 years
Secondary	Overall Survival	Measured as the time of surgery until death from any cause	5 years
Secondary	Development of Lymph Node or Distant Metastasis	Defined as yes/no for each type of metastasis	5 years