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NCT Number: NCT06400550

Identification of Metabolic Phenotypes Associated With Melanoma Metastasis

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

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Key information

Conditions

Melanoma (Skin) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Aleuna Lee

CONTACT

[email protected]

2146458968

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Glucose Utilisation in the TCA cycle

    Time frame: 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 outcomes

  1. Relapse free survival

    Time frame: 5 years

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

  2. Overall Survival

    Time frame: 5 years

    Measured as the time of surgery until death from any cause

  3. Development of Lymph Node or Distant Metastasis

    Time frame: 5 years

    Defined as yes/no for each type of metastasis

Other outcomes

  1. Tumor Metabolomic and Lipidomic Profiling

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aleuna Lee

CONTACT

[email protected]

2146458968

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
May 6, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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