Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06650592
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Axillary skin swabs of each axilla for microbiome analysis', 'timeFrame': '1 Day', 'description': 'Characterize the axillary microbiome in limbs that have been treated with ILR compared to those that were unaffected.'}], 'primaryOutcomes': [{'measure': 'The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference', 'timeFrame': '1 Day'}, {'measure': 'the efficacy of immediate lymphatic reconstruction (ILR) based on volume', 'timeFrame': '1 Day'}, {'measure': 'the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database.', 'timeFrame': '1 Day'}, {'measure': 'the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database.', 'timeFrame': '1 Day'}], 'secondaryOutcomes': [{'measure': 'the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)', 'timeFrame': '1 Day', 'description': 'This is an 18 questionnaire that has a scale from 0 (no pain) to 4 (severe pain)'}, {'measure': 'the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire', 'timeFrame': '1 Day', 'description': 'This is a 30 questionnaire that has a scale from 1 (No difficulty) to 5 (unable)'}, {'measure': 'the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)', 'timeFrame': '1 Day', 'description': 'This is a 17 questionnaire that scales from unable to do it to not difficult.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphatic Reconstruction']}, 'descriptionModule': {'briefSummary': 'Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema. It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage. Although ILR carries significant promise in prevention of lymphedema, there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet. The University of Chicago Comprehensive Cancer Center (UCCCC) is one of the busiest microsurgery centers performing this procedure, and, as a Lymphedema Center of Excellence, is in a unique position to investigate the efficacy of ILR in preventing lymphedema. In addition, the University has access to a world class microbiome research facility and colleagues. There is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema. Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention. The purpose of this study is to determine the role of immediate lymphatic reconstruction and obtain objective data to correlate the existing, self-reported rates of lymphedema at the University of Chicago.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The University of Chicago has a prospectively maintained database (LYMPHA Database) of all patients who were candidates for ILR.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who were candidates for Immediate Lymphatic Reconstruction (ILR)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06650592', 'briefTitle': 'Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA', 'orgStudyIdInfo': {'id': 'IRB24-1513'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients who were candidates for immediate lymphatic reconstruction (ILR)', 'description': 'All patients who were candidates for immediate lymphatic reconstruction (ILR) in the LYMPHA Database', 'interventionNames': ['Other: All patients who were candidates for immediate lymphatic reconstruction (ILR)']}], 'interventions': [{'name': 'All patients who were candidates for immediate lymphatic reconstruction (ILR)', 'type': 'OTHER', 'description': 'All patients who were candidates for immediate lymphatic reconstruction (ILR)', 'armGroupLabels': ['All patients who were candidates for immediate lymphatic reconstruction (ILR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leila Yazdanbakhsh', 'role': 'CONTACT', 'email': 'leila.yazdanbakhsh@bsd.uchicago.edu', 'phone': '773-834-5087'}, {'name': 'Carlisa Dixon', 'role': 'CONTACT', 'email': 'cdixon520@bsd.uchicago.edu', 'phone': '773-834-4337'}, {'name': 'Summer Hanson, MD, PhD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University o Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Summer Hanson, MD, PhD, FACS', 'role': 'CONTACT', 'email': 'sehanson@bsd.uchicago.edu', 'phone': '(773) 702-6302'}, {'name': 'Leila Yazdanbakhsh', 'role': 'CONTACT', 'email': 'leila.yazdanbakhsh@bsd.uchicago.edu', 'phone': '773-834-5087'}], 'overallOfficials': [{'name': 'Summer Hanson, MD, PhD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}