NCT06400550

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Aug 2018Aug 2028

Study Start

First participant enrolled

August 1, 2018

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

10 years

First QC Date

May 1, 2024

Last Update Submit

May 6, 2025

Conditions

Melanoma (Skin)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Relapse free survival

    5 years

  • Overall Survival

    5 years

  • Development of Lymph Node or Distant Metastasis

    5 years

Other Outcomes (1)

  • Tumor Metabolomic and Lipidomic Profiling

    5 years

Study Arms (2)

13C-glucose infusion

Tumor samples of patients who receive the optional 13C-glucose infusion will be studied using flux analysis and metabolomic profiling.

No 13C-glucose infusion

Tumor samples of patients who do not receive the optional 13C-glucose infusion will be studied using metabolomic profiling alone.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years of age with a suspected malignant melanoma

You may qualify if:

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

You may not qualify if:

  • Not a surgical candidate
  • Poorly controlled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jennifer Gill, MD, PhD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleuna Lee

CONTACT

2146458968aleuna.lee@utsouthwestern.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 6, 2024

Study Start

August 1, 2018

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)