Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-27 @ 8:05 AM
Study NCT ID:
NCT03034395
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2017-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.', 'timeFrame': '2 years', 'description': 'Number of patients who agree to participate'}], 'secondaryOutcomes': [{'measure': 'Recurrence (disease free survival)', 'timeFrame': 'Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years', 'description': 'Subjects will be evaluated at 4 month intervals for 2 years and then at 4-6 month intervals for an additional 3 years to evaluate for evidence of disease recurrence.'}, {'measure': 'Quality of life following surgery', 'timeFrame': 'One month post-surgery', 'description': 'Measured by FACT-Melanoma Surgery Subscale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'cT2N0M0'], 'conditions': ['Malignant Melanoma']}, 'descriptionModule': {'briefSummary': 'This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.', 'detailedDescription': 'After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven T2 malignant melanoma.\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2.\n\nExclusion Criteria:\n\n* Visible additional disease that suggests a greater than T2 malignant melanoma\n* Unable to tolerate general anesthesia\n* Evidence of distant metastatic disease\n* Melanoma located on face or digits'}, 'identificationModule': {'nctId': 'NCT03034395', 'briefTitle': 'Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Pilot Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma', 'orgStudyIdInfo': {'id': 'IIT-2016-JM-MEL-T2Margins'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Wide Local Excision 1cm', 'interventionNames': ['Procedure: Wide Local Excision']}, {'type': 'OTHER', 'label': 'Wide Local Excision 2cm', 'interventionNames': ['Procedure: Wide Local Excision']}], 'interventions': [{'name': 'Wide Local Excision', 'type': 'PROCEDURE', 'description': 'Surgery', 'armGroupLabels': ['Wide Local Excision 1cm', 'Wide Local Excision 2cm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Joshua Mammen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}