Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-30 @ 11:24 PM
Study NCT ID:
NCT01500304
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Groin Dissection for 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2011-12-22', 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proficiency score per surgery', 'timeFrame': 'Approximately 90 days following surgical procedure', 'description': 'The proficiency score is a function of the lymph nodes pathologically identified, the amount of blood transfused and the operative time. The range is 0 to 3, with higher proficiency in performing the procedure being 3.'}], 'secondaryOutcomes': [{'measure': 'Morbidity and percentage of patients converted to open surgical procedure', 'timeFrame': 'Approximately 90 days following surgical procedure', 'description': 'Perioperative morbidity will be prospectively collected and reported.Percentage of participants that require conversion from MILND to open procedure (standard of care). Conversion to the open procedure is required if the operation is not progressing, an adequate oncologic procedure cannot be completed or if bleeding is encountered that cannot be safety controlled videoscopically.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Melanoma', 'Lymph Nodes', 'Lymph Node Dissection', 'Minimally invasive'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '17336247', 'type': 'BACKGROUND', 'citation': 'Jakub JW, Reintgen DS, Shivers S, Pendas S. Regional node dissection for melanoma: techniques and indication. Surg Oncol Clin N Am. 2007 Jan;16(1):247-61. doi: 10.1016/j.soc.2006.10.012.'}, {'pmid': '22875645', 'type': 'BACKGROUND', 'citation': 'Abbott AM, Grotz TE, Rueth NM, Hernandez Irizarry RC, Tuttle TM, Jakub JW. Minimally invasive inguinal lymph node dissection (MILND) for melanoma: experience from two academic centers. Ann Surg Oncol. 2013 Jan;20(1):340-5. doi: 10.1245/s10434-012-2545-6. Epub 2012 Aug 9.'}, {'pmid': '28009745', 'type': 'DERIVED', 'citation': 'Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S Jr, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Grotz TE, Allred JB, Suman VJ, Brady MS, Tyler D, Wayne JD, Nelson H. Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial. Ann Surg. 2017 Jan;265(1):192-196. doi: 10.1097/SLA.0000000000001670.'}, {'pmid': '26711792', 'type': 'DERIVED', 'citation': 'Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S Jr, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Allred JB, Suman VJ, Grotz TE, Zendejas B, Wayne JD, Tyler DS. Training High-Volume Melanoma Surgeons to Perform a Novel Minimally Invasive Inguinal Lymphadenectomy: Report of a Prospective Multi-Institutional Trial. J Am Coll Surg. 2016 Mar;222(3):253-60. doi: 10.1016/j.jamcollsurg.2015.11.010. Epub 2015 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.', 'detailedDescription': 'This study is a multi-center, Phase 1 clinical trial to determine the safety and feasibility of minimally invasive inguinal lymph node dissection for patients with melanoma. Licensed surgeons who have undergone special training, including a course at the Mayo Clinic Rochester in minimally invasive lymph node dissection (MILND) will perform the new procedure at their home institutions. The study will characterize the learning curve of MILND in the clinical setting, and evaluate the safety of the new operative technique.\n\nThe hypotheses for this study are: 1) minimally invasive groin dissection is a safe procedure. 2) a structured educational training program is a feasible and effective method to train practicing surgeons in this novel procedure and 3) pre-course generic laparoscopic technical skills correlate with minimally invasive superficial groin dissection performance in a clinical setting, including operative oncologic standards and safety metrics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection.\n* Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable.\n* Clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable.\n* Patients must be Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics).\n* Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year.\n* Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment.\n\nExclusion Criteria:\n\n* Prior ipsilateral superficial inguinal lymph node dissection\n* Invasion or ulceration of inguinal nodal disease into the overlying skin\n* Prior radiation therapy to the same regional nodal basin.'}, 'identificationModule': {'nctId': 'NCT01500304', 'acronym': 'SAFE-MILND', 'briefTitle': 'Minimally Invasive Groin Dissection for Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma', 'orgStudyIdInfo': {'id': '10-007790'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minimally invasive surgery', 'description': 'Minimally invasive inguinal lymph node dissection is a 10-step technique to provide novel inguinal lymph node staging and treatment.', 'interventionNames': ['Procedure: Minimally invasive inguinal lymph node dissection']}], 'interventions': [{'name': 'Minimally invasive inguinal lymph node dissection', 'type': 'PROCEDURE', 'otherNames': ['SAFE MILND'], 'description': 'Operative intervention will be a minimally invasive inguinal lymphadenectomy, which is a three trocar technique to the inguinal dissection, that respects the same anatomic boundaries as the conventional open procedure', 'armGroupLabels': ['Minimally invasive surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'John Wayne Cancer Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'James Jakub, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Breast and Melanoma Surgery Section Head', 'investigatorFullName': 'James W. Jakub', 'investigatorAffiliation': 'Mayo Clinic'}}}}