Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 11:29 PM
Study NCT ID:
NCT03879395
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2019-03-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D000008', 'term': 'Abdominal Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059146', 'term': 'Metastasectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2019-03-15', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'December 2018', 'description': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Complications according to Clavien-Dindo within 90 days.', 'timeFrame': '90 days', 'description': 'Complications according to Clavien-Dindo within 90 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melanoma', 'abdominal metastasis', 'metastasectomy', 'tumor resection', 'M1c'], 'conditions': ['Melanoma Stage Iv', 'Melanoma Metastatic', 'Abdominal Tumor']}, 'referencesModule': {'references': [{'pmid': '31299988', 'type': 'DERIVED', 'citation': 'Holmberg CJ, Alwan G, Ny L, Olofsson Bagge R, Katsarelias D. Surgery for gastrointestinal metastases of malignant melanoma - a retrospective exploratory study. World J Surg Oncol. 2019 Jul 12;17(1):123. doi: 10.1186/s12957-019-1663-z.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to conduct a single centre retrospective study of all patients with stage IV melanoma that underwent surgery for metastases at Sahlgrenska University Hospital between 2010-01-01 and 2018-12-31. Pre- and postoperative data will be collected from digital medical records, the Swedish Cancer Registry, the Swedish Cause of Death Register as well as from the national Swedish cancer patient database (INCA). If needed, patient records will be collected from other hospitals. Results will be presented in written format as a summary and analysis of the characteristics of the cases operated on during the inclusion period.\n\nThe aim is to identify predictive and prognostic factors for outcome and complications in the surgical treatment of stage IV metastatic melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with abdominally metastasized malignant melanoma stage IV.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy verified stage IV malignant melanoma, stage M1c.\n* Having undergone surgery with metastasectomy of melanoma tumors.\n\nExclusion Criteria:\n\n* retroperitoneal tumors'}, 'identificationModule': {'nctId': 'NCT03879395', 'acronym': 'SurgMelMet', 'briefTitle': 'Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'SurgMelMet'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'Patients with stage IV malignant melanoma with abdominal metastasis (M1c) that underwent abdominal surgery with metastasectomy during the study period.', 'interventionNames': ['Procedure: Abdominal surgery with metastasectomy']}], 'interventions': [{'name': 'Abdominal surgery with metastasectomy', 'type': 'PROCEDURE', 'description': 'Emergency or elective surgery on indications related to abdominally metastasized malignant melanoma', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data to be made available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Senior Consultant Surgeon', 'investigatorFullName': 'Roger Olofsson Bagge', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}