Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-29 @ 10:14 PM
Study NCT ID:
NCT01136369
Status:
COMPLETED
Last Update Posted:
2010-06-03
First Post:
2010-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples of the tissue homogenate will be retained and may be used for for further testing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 496}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-02', 'studyFirstSubmitDate': '2010-06-01', 'studyFirstSubmitQcDate': '2010-06-02', 'lastUpdatePostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section staining.', 'timeFrame': '2 years'}, {'measure': 'The time required to perform the trial method will be measured and evaluated for intra-operative use.', 'timeFrame': '2 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metastasis', 'molecular pathology'], 'conditions': ['Breast Neoplasms', 'Breast Diseases']}, 'descriptionModule': {'briefSummary': 'The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section Hematoxylin and Eosin (H\\&E) and IHC staining.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female patients, over the age of 18, diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel node dissection.\n* Patients who have read and understand the informed consent form and are capable and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast cancers.\n* Patients diagnosed with inflammatory breast cancer.\n* Patients diagnosed with ductal carcinoma in situ (DCIS) when breast conserving is to be done.\n* Patients who are pregnant, as confirmed by a patient/treating physician interview.\n* Patients with suspicious palpable axillary lymph nodes.\n* Patients currently being treated for or previously diagnosed with, another type of carcinoma.\n* Patients who have undergone prior non-oncologic breast surgery or axillary surgery.\n* Patients who have received pre-operative systemic therapy.\n* Patients who are incapable of providing written informed consent.\n* Patients who have been judged to be inappropriate by a medical care provider (i.e. surgeon, oncologist, pathologists, etc.).'}, 'identificationModule': {'nctId': 'NCT01136369', 'briefTitle': 'Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sysmex America, Inc.'}, 'officialTitle': 'Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer', 'orgStudyIdInfo': {'id': 'OSNA-BC-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSNA Breast Cancer System', 'interventionNames': ['Device: OSNA Breast Cancer System']}], 'interventions': [{'name': 'OSNA Breast Cancer System', 'type': 'DEVICE', 'description': 'For in vitro diagnostic use only.\n\nThe OSNA Breast Cancer System is an automated semi-quantitative, in vitro diagnostic test for the rapid detection of greater than (\\>) 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes and to aid in patient staging. An assay positive + or ++ result indicates the presence of metastasis (\\> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (\\> 2 mm).\n\nPost-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Sysmex lymph node cutting scheme, is required.', 'armGroupLabels': ['OSNA Breast Cancer System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'John Wayne Cancer Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '30062', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'WellStar Health Systems', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Medical School', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Central Carolina Surgery, PA', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43081', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Breast Care Specialist, Inc.', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Breast Care Specialist, PC', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville Breast Center, PC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Surgical Group', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sysmex America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Carrie Pineda', 'oldOrganization': 'Sysmex America, Inc'}}}}