Identification of Metabolic Phenotypes Associated With Melanoma Metastasis

NCT ID: NCT06400550

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2028-08-01

Brief Summary

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

Detailed Description

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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

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Melanoma (Skin)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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13C-glucose infusion

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

No interventions assigned to this group

No 13C-glucose infusion

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Gill

ASSISTANT PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Gill, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aleuna Lee

Role: CONTACT

2146458968

Facility Contacts

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Aleuna Lee

Role: primary

2146458968

Other Identifiers

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STU 052018-031

Identifier Type: -

Identifier Source: org_study_id

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