Identification of Metabolic Phenotypes Associated With Melanoma Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Melanoma (Skin). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Glucose Utilisation in the TCA cycle [Time frame: 5 years]
Secondary outcome measures (3)
- Relapse free survival [Time frame: 5 years]
- Overall Survival [Time frame: 5 years]
- Development of Lymph Node or Distant Metastasis [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT06400550 · STU 052018-031