Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-28 @ 4:04 PM
Study NCT ID:
NCT06400550
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2024-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Metabolic Phenotypes Associated With Melanoma Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tumor Metabolomic and Lipidomic Profiling', 'timeFrame': '5 years', 'description': 'Abundance of metabolites and lipid species, quantified by liquid chromatography mass spectrometry'}], 'primaryOutcomes': [{'measure': 'Glucose Utilisation in the TCA cycle', 'timeFrame': '5 years', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Relapse free survival', 'timeFrame': '5 years', 'description': 'Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first'}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'Measured as the time of surgery until death from any cause'}, {'measure': 'Development of Lymph Node or Distant Metastasis', 'timeFrame': '5 years', 'description': 'Defined as yes/no for each type of metastasis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to observe metabolic features associated with human melanoma tumors.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years of age with a suspected malignant melanoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.\n* Subjects of all races and ethnic origins over age 18.\n\nExclusion Criteria:\n\n* Not a surgical candidate\n* Poorly controlled diabetes'}, 'identificationModule': {'nctId': 'NCT06400550', 'briefTitle': 'Identification of Metabolic Phenotypes Associated With Melanoma Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Identification of Metabolic Phenotypes Associated With Melanoma Metastasis', 'orgStudyIdInfo': {'id': 'STU 052018-031'}}, 'armsInterventionsModule': {'armGroups': [{'label': '13C-glucose infusion', 'description': 'Tumor samples of patients who receive the optional 13C-glucose infusion will be studied using flux analysis and metabolomic profiling.'}, {'label': 'No 13C-glucose infusion', 'description': 'Tumor samples of patients who do not receive the optional 13C-glucose infusion will be studied using metabolomic profiling alone.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aleuna Lee', 'role': 'CONTACT', 'email': 'aleuna.lee@utsouthwestern.edu', 'phone': '2146458968'}], 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Aleuna Lee', 'role': 'CONTACT', 'email': 'aleuna.lee@utsouthwestern.edu', 'phone': '2146458968'}], 'overallOfficials': [{'name': 'Jennifer Gill, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR', 'investigatorFullName': 'Jennifer Gill', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}