Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-31 @ 6:15 AM
Study NCT ID:
NCT03135392
Status:
WITHDRAWN
Last Update Posted:
2018-11-14
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016462', 'term': 'Mammaplasty'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D016067', 'term': 'Nerve Transfer'}], 'ancestors': [{'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants who are having implant reconstruction will act as controls for all other breast reconstructions. If the participant is having autologous tissue reconstruction, she will be randomly put into one of the study groups. Neither the study doctor nor the participant can choose the treatment. Assignment is done randomly, like the flip of a coin. If the participant is having only one breast reconstructed, she will be randomly assigned to either receive the nerve reconstruction or not.\n\nIf the participant is having both of her breasts reconstructed, one side will receive the nerve reconstruction and one will not. The participant will not know which group you have been assigned to until the completion of the study or if voluntarily withdraw from the study'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Research cancelled because of inadequate staffing.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-12', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite measure of sensation', 'timeFrame': 'Up to 24 months after surgery', 'description': 'Differences of at least 20% comparing control to experimental breasts would be clinically meaningful. Composite measure will be calculated by combining the follow binomial factors: detection of temperature difference (feeling hot and cold), detection of sharp versus dull pressure, detection of vibration, discerning point pressure'}], 'secondaryOutcomes': [{'measure': 'Quality of Life as measured by a 19-question survey regarding sensation and appearance of breast.', 'timeFrame': 'Up to 24 months after surgery', 'description': 'A total of 19 Likert scale questions will be given to participants in the pre- and post-Surgical Sensation Questionnaire regarding sensation and appearance of breast before and after reconstruction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'sensation recovery', 'Neurotization'], 'conditions': ['Mastectomy', 'Breast Reconstruction']}, 'descriptionModule': {'briefSummary': 'Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.\n\nAutologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following surgery.', 'detailedDescription': 'To determine the timing and distribution of sensation recovery of breast after mastectomy and breast reconstruction, both with autologous and implant-based reconstruction. Also, to determine the role of innervated free tissue transfer in breast reconstruction.\n\nSpecific Aims\n\n1. Determine the timing and degree of return of breast in women who underwent mastectomy with autologous tissue or with implant based reconstruction.\n2. Determine sensation following neurotized free flap reconstruction\n3. Determine whether neurotization has an impact on quality of life measures post operatively\n\nStudy Design Patients will be enrolled prospectively in this data collection study in which they will receive the standard of care for breast cancer resection and oncologically safe and accepted means of breast reconstruction with tissue expander and/or prosthetic implants. Patients will receive additional, non-invasive sensory testing, performed at standard follow up intervals in clinic by their reconstructive team. All patients participating in the study will be consented for enrollment at the pre-operative visit by either the surgeon or physician assistant. As this is a prospective study, all women fitting inclusion criteria over a 6-month minimal, but projected goal 12-month period will be included.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing unilateral or bilateral skin sparing mastectomy for breast cancer\n* Patient must have one of the following reconstructions in planned:\n\n * Immediate tissue expander placement\n * Immediate implant placement\n * Immediate autologous breast reconstruction\n* All patients participating in the study must be willing to be consented for enrollment at the pre-operative visit.\n\nExclusion Criteria:\n\n* Pre-operative radiation therapy\n* Any pre-excising\n* Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"'}, 'identificationModule': {'nctId': 'NCT03135392', 'briefTitle': 'Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Return of Breast Sensation Following Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer: An Evaluation of Clinical, Sensory, and Quality of Life Outcomes', 'orgStudyIdInfo': {'id': 'CASE2117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Breast Reconstruction with Artificial Implant', 'description': 'Participants undergoing unilateral reconstruction: patient will serve as internal control with contralateral breast and reconstructed breast will be compared to all other reconstructed breasts. Participants undergoing bilateral reconstruction: reconstructed breasts will be compared to all other reconstructed breasts', 'interventionNames': ['Procedure: Breast Reconstruction with Artificial Implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Autologous Breast Reconstruction without Neurotization', 'description': 'Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery', 'interventionNames': ['Procedure: Autologous Breast Reconstruction']}, {'type': 'EXPERIMENTAL', 'label': 'Autologous Breast Reconstruction with Neurotization', 'description': 'Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during surgery.', 'interventionNames': ['Procedure: Autologous Breast Reconstruction', 'Procedure: Neurotization']}], 'interventions': [{'name': 'Breast Reconstruction with Artificial Implant', 'type': 'PROCEDURE', 'description': 'Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants', 'armGroupLabels': ['Breast Reconstruction with Artificial Implant']}, {'name': 'Autologous Breast Reconstruction', 'type': 'PROCEDURE', 'description': "Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue", 'armGroupLabels': ['Autologous Breast Reconstruction with Neurotization', 'Autologous Breast Reconstruction without Neurotization']}, {'name': 'Neurotization', 'type': 'PROCEDURE', 'otherNames': ['Nerve Reconstruction'], 'description': 'Nerve will be reconstructed during autologous breast tissue reconstruction', 'armGroupLabels': ['Autologous Breast Reconstruction with Neurotization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Andrea Moreira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}