Identification of Metabolic Phenotypes Associated With Melanoma Metastasis

ConditionMelanoma (Skin)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Texas Southwestern Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.

Subjects of all races and ethnic origins over age 18.

Disqualifiers

Not a surgical candidate

Poorly controlled diabetes

Trial population

Patients over 18 years of age with a suspected malignant melanoma

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants

are grouped into 2 trial groups

Group A: 13C-glucose infusion

Group B: No 13C-glucose infusion

Trial outcomes

Primary outcomes

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)

Time frame

5 years

Secondary outcomes

Relapse free survival

Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first

Time frame

5 years

Overall Survival

Measured as the time of surgery until death from any cause

Time frame

5 years

Development of Lymph Node or Distant Metastasis

Defined as yes/no for each type of metastasis

Time frame

5 years

Other outcomes

Tumor Metabolomic and Lipidomic Profiling

Abundance of metabolites and lipid species, quantified by liquid chromatography mass spectrometry

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Source ClinicalTrials.gov

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