Melanoma (Skin)NCT06400550
Identification of Metabolic Phenotypes Associated With Melanoma Metastasis
An observational study of Melanoma (Skin), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this study is to observe metabolic features associated with human melanoma tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age with a suspected malignant melanoma
Who may be able to join
- Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.
- Subjects of all races and ethnic origins over age 18.
Who cannot join
- Not a surgical candidate
- Poorly controlled diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Aleuna Lee, 2146458968, aleuna.lee@utsouthwestern.edu
About this study
The goal of this study is to observe metabolic features associated with human melanoma tumors.
Read the 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.
- Conditions
- Melanoma (Skin)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 years
Secondary outcomes (3)
Relapse free survival
Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first
Measured: 5 years
Overall Survival
Measured as the time of surgery until death from any cause
Measured: 5 years
Development of Lymph Node or Distant Metastasis
Defined as yes/no for each type of metastasis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Aug 2018
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Gill, University of Texas Southwestern Medical Center
- Investigators
- Jennifer Gill, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400550
- Sponsor's protocol ID
- STU 052018-031
- Status last verified
- Jun 2026
- First submitted
- 1 May 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Metabolic Phenotypes Associated With Melanoma Metastasis
- ClinicalTrials.gov ID
- NCT06400550
- Acronym / sponsor ID
- STU 052018-031
- Conditions
- Melanoma (Skin)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age with a suspected malignant melanoma
Key inclusion criteria (2 listed)
- Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.
- Subjects of all races and ethnic origins over age 18.
Key exclusion criteria (2 listed)
- Not a surgical candidate
- Poorly controlled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Relapse free survival
Time frame: 5 years
Overall Survival
Time frame: 5 years
Development of Lymph Node or Distant Metastasis
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Gill, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin), run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleuna Lee (2146458968, aleuna.lee@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Utilisation in the TCA cycle (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.