Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-03-22 @ 10:46 AM
Study NCT ID:
NCT02948751
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2016-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D055756', 'term': 'Meningeal Carcinomatosis'}], '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'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kk2693@columbia.edu', 'phone': '212-305-0170', 'title': 'Kevin Kalinsky, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'OncoCEE', 'description': "Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.\n\nOncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OncoCEE', 'description': "Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.\n\nOncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA)."}], 'classes': [{'title': 'Detected by OncoCEE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Detected by standard lumbar puncture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Total number of participants with leptomeningeal metastasis detected (ER status)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes patients with metastatic breast cancer enrolled with matched samples.'}, {'type': 'PRIMARY', 'title': 'Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OncoCEE', 'description': "Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.\n\nOncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA)."}], 'classes': [{'title': 'Detected by OncoCEE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Detected by standard lumbar puncture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Total number of participants with leptomeningeal metastasis detected (HER2 status)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes patients with metastatic breast cancer enrolled with matched samples.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OncoCEE', 'description': "Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.\n\nOncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OncoCEE', 'description': "Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.\n\nOncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA)."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-17', 'size': 742001, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-25T18:13', 'hasProtocol': True}, {'date': '2019-01-30', 'size': 334410, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-10T15:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2016-10-27', 'resultsFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-10', 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)', 'timeFrame': '6 months', 'description': 'Total number of participants with leptomeningeal metastasis detected (ER status)'}, {'measure': 'Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)', 'timeFrame': '6 months', 'description': 'Total number of participants with leptomeningeal metastasis detected (HER2 status)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isUnapprovedDevice': True}, 'conditionsModule': {'keywords': ['Breast Carcinoma', 'Breast tumors', 'Cancer of the Breast', 'Malignant tumor of the breast', 'breast cancer', 'leptomeningeal metastasis'], 'conditions': ['Breast Cancer', 'Leptomeningeal Metastasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://hiccc.columbia.edu/clinicaltrials', 'label': 'Herbert Irving Comprehensive Cancer Center (HICCC) Clinical Trials Page'}]}, 'descriptionModule': {'briefSummary': 'This study will prospectively enroll 36 evaluable subjects with breast cancer who are undergoing workup for clinical suspicion of leptomeningeal metastasis (LM). Neuroimaging consisting of MRI of the brain or total spine (or both, as clinically indicated) will be obtained in all patients. Patients will also undergo a lumbar puncture and standard CSF evaluation, which may consist of intracranial pressure measurement, CSF protein, glucose, white and red cell analysis, infectious cultures, as well as conventional cytopathologic analysis (cytocentrifuge). An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.', 'detailedDescription': 'Leptomeningeal metastasis (LM) is a condition in which cancer cells seed the meninges and may go on to invade the brain parenchyma, spinal cord, cranial nerves or peripheral nerves. It is a devastating complication of breast cancer, and is often considered in the differential diagnosis when patients with breast cancer present with new neurologic symptoms. It was previously thought to be a rare occurrence, but autopsy series have shown the true overall incidence to be up to 8%. In fact, while the incidence of meningeal metastasis from other malignancies has decreased, the opposite is true of breast cancer, in which clinical evidence suggests an increasing incidence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18 years or older) patients, with invasive breast cancer, of all racial and ethnic origins\n* Undergoing lumbar puncture for clinical or radiographic suspicion of leptomeningeal metastasis\n* Provide study-specific informed consent\n* Patients with unequivocal or suspicious MRI findings.\n* Of those with a definitive diagnosis of LM (i.e. positive CSF cytology), 10 evaluable patients will be accrued.\n\nExclusion Criteria:\n\n* Prior CSF fluid which identified malignant cells after 10 evaluable patients with positive CSF are accrued.'}, 'identificationModule': {'nctId': 'NCT02948751', 'briefTitle': 'Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Pilot Study Evaluating the Utility of OncoCEE (Cell Enrichment and Extraction) Technology, a Novel Immunocytochemical Microfluidic Device, in the Diagnosis of Leptomeningeal Metastasis (LM) From Breast Cancer Through Identification of Circulating Tumor Cells (CTCs) in Cerebrospinal Fluid (CSF)', 'orgStudyIdInfo': {'id': 'AAAQ4761'}, 'secondaryIdInfos': [{'id': 'R03CA208547-01', 'link': 'https://reporter.nih.gov/quickSearch/R03CA208547-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OncoCEE', 'description': 'Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.', 'interventionNames': ['Device: OncoCEE']}], 'interventions': [{'name': 'OncoCEE', 'type': 'DEVICE', 'otherNames': ['OncoCEETM microchannel technology'], 'description': "The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).", 'armGroupLabels': ['OncoCEE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'timeFrame': '"A description of when the IPD and any additional supporting information will become available and for how long, including the start and end dates or period of availability. This may be provided as an absolute date (for example, starting in January 2025) or as a date relative to the time when summary data are published or otherwise made available (for example, starting 6 months after publication)."', 'ipdSharing': 'YES', 'description': 'In order to fulfill the requirement of sharing the data obtained in the research program, a website where the data acquired will be made available to the scientific community. Through this website, colleagues from other research centers will be able to read about the general information of the proposal, including its objectives and aims. The website will be updated on a regular basis (at least quarterly) to include the advances achieved during the research activities and new results obtained from data processing and statistical analysis. Hyperlinks pointing to other web pages with information related to the program will also be available on our website. These hyperlinks will be divided in those with information for patients and those with information for researchers.\n\n"briefly describe what specific individual participant data sets are to be shared (for example, all collected IPD, all IPD that underlie results in a publication)."', 'accessCriteria': '"Describe by what access criteria IPD and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism. Information about who will review requests and criteria for reviewing requests may also be provided."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Biocept, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}