Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-09 @ 5:59 PM
Study NCT ID:
NCT03139435
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rstrowd@wakehealth.edu', 'phone': '336-713-5440', 'title': 'Roy Strowd', 'organization': 'Wake Forest Baptist Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'Adverse Events were collected during the first treatment cycle. Historical control participants were not a part of this trial and were used as a reference group only. No adverse events were collected from this group.', 'eventGroups': [{'id': 'EG000', 'title': 'Case', 'description': 'Study sample', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tibial Nerve Cross-sectional Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'arm', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Case', 'description': 'Study sample'}, {'id': 'OG001', 'title': 'Control', 'description': 'Historical Control'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days', 'description': 'Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'arm', 'denomUnitsSelected': 'arm'}, {'type': 'SECONDARY', 'title': 'Amplitude of Nerve Response - Ankle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'arm', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Case', 'description': 'Study sample'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (amplitude of nerve response - ankle).", 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'arm', 'denomUnitsSelected': 'arm'}, {'type': 'SECONDARY', 'title': 'Conduction Velocity of Nerve Response - Tibial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'arm', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Case', 'description': 'Study sample'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (conduction velocity of nerve response - tibial).", 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'arm', 'denomUnitsSelected': 'arm'}, {'type': 'SECONDARY', 'title': 'Distal Latency of Nerve Response - Ankle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'arm', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Case', 'description': 'Study sample'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (distal latency of nerve response - ankle).", 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'arm', 'denomUnitsSelected': 'arm'}, {'type': 'SECONDARY', 'title': 'Nerve Fiber Density in the Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'arm', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Case', 'description': 'Study sample'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and distal intraepidermal nerve fiber density.", 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'arm', 'denomUnitsSelected': 'arm'}, {'type': 'SECONDARY', 'title': 'Self-reported Neuropathy Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Case', 'description': 'Study sample'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days', 'description': "Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale.", 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sural Nerve Cross-sectional Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'arm', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Case', 'description': 'Study sample'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days', 'description': "Will be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable.", 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'arm', 'denomUnitsSelected': 'arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Levels of Inflammatory Molecules', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Number of Activated Mast Cells', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Case', 'description': 'Study sample'}, {'id': 'FG001', 'title': 'Historical Control', 'description': 'Historical Control group - not part of study enrollment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': "For those enrolled during the study ('Case'), only one measure per participant is analyzed.", 'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '20'}, {'comment': "For the 'Historical Control' arm there are two samples for each participant (one from each arm).", 'groupId': 'FG001', 'numUnits': '120', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '20'}, {'groupId': 'FG001', 'numUnits': '120', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'nerve samples', 'preAssignmentDetails': 'Historical control information is a reference group only and were not active participants in this trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'units': 'nerve samples', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Case', 'description': 'Study sample'}, {'id': 'BG001', 'title': 'Control (From Another Study)', 'description': 'These patients were not enrolled as part of this study. This data comes from another study. Each of these n=60 patients had tests done on both left and right arms, which creates the n=120 samples found in the results.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '72'}, {'value': '45.9', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '80'}, {'value': '48.3', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'nerve samples'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-09', 'size': 921220, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-17T17:33', 'hasProtocol': True}, {'date': '2019-01-22', 'size': 198445, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-05-08T12:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2017-05-01', 'resultsFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2017-05-01', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-04', 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum Levels of Inflammatory Molecules', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients."}, {'measure': 'The Number of Activated Mast Cells', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients."}], 'primaryOutcomes': [{'measure': 'Tibial Nerve Cross-sectional Area', 'timeFrame': 'Up to 30 days', 'description': 'Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due'}], 'secondaryOutcomes': [{'measure': 'Amplitude of Nerve Response - Ankle', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (amplitude of nerve response - ankle)."}, {'measure': 'Conduction Velocity of Nerve Response - Tibial', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (conduction velocity of nerve response - tibial)."}, {'measure': 'Distal Latency of Nerve Response - Ankle', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (distal latency of nerve response - ankle)."}, {'measure': 'Nerve Fiber Density in the Skin', 'timeFrame': 'Up to 30 days', 'description': "Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and distal intraepidermal nerve fiber density."}, {'measure': 'Self-reported Neuropathy Score', 'timeFrame': 'Up to 30 days', 'description': "Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale."}, {'measure': 'Sural Nerve Cross-sectional Area', 'timeFrame': 'Up to 30 days', 'description': "Will be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peripheral Neuropathy', 'Stage 0 Breast Cancer', 'Stage I Breast Cancer', 'Stage IA Breast Cancer', 'Stage IB Breast Cancer', 'Stage II Breast Cancer', 'Stage IIA Breast Cancer', 'Stage IIB Breast Cancer', 'Stage III Breast Cancer', 'Stage IIIA Breast Cancer', 'Stage IIIB Breast Cancer', 'Stage IIIC Breast Cancer', 'Stage IV Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults.\n\nSECONDARY OBJECTIVES:\n\nI. To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults.\n\nII. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients.\n\nIII. To determine if the above changes in nerve CSA correlate with changes on a self-reported neuropathy scale (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 \\[QLQ-CIPN20\\]) in the same TIPN patients.\n\nIV. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same TIPN patients.\n\nTERTIARY OBJECTIVES:\n\nI. To assess activated mast cells in skin biopsies in TIPN patients in relation to severity of symptoms and above findings.\n\nII. To assess serum inflammatory markers in TIPN patients in relation to severity of symptoms and above findings.\n\nOUTLINE:\n\nPatients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.\n\nAfter completion of study, patients are followed up for 30 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer (any stage)\n* Previously or currently receiving taxane-based chemotherapy\n* Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy\n* Ability and willingness to understand and sign an informed consent\n\nExclusion Criteria:\n\n* Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy\n* Unable to provide history'}, 'identificationModule': {'nctId': 'NCT03139435', 'briefTitle': 'Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'IRB00043631'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00680', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CCCWFU 97217', 'type': 'OTHER', 'domain': 'Comprehensive Cancer Center of Wake Forest University'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (ultrasound)', 'description': 'Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.', 'interventionNames': ['Procedure: Biopsy', 'Other: Questionnaire Administration', 'Diagnostic Test: Ultrasound Tomography']}], 'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Bx'], 'description': 'Undergo skin biopsy', 'armGroupLabels': ['Diagnostic (ultrasound)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Diagnostic (ultrasound)']}, {'name': 'Ultrasound Tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Undergo peripheral nerve ultrasound', 'armGroupLabels': ['Diagnostic (ultrasound)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Roy Strowd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}