Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer
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)
2 other identifiers
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedStudy Start
First participant enrolled
February 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2019
CompletedResults Posted
Study results publicly available
June 6, 2024
CompletedJune 6, 2024
May 1, 2024
2.9 years
October 27, 2016
August 25, 2021
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)
Total number of participants with leptomeningeal metastasis detected (ER status)
6 months
Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)
Total number of participants with leptomeningeal metastasis detected (HER2 status)
6 months
Study Arms (1)
OncoCEE
EXPERIMENTALPatients 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Adult (18 years or older) patients, with invasive breast cancer, of all racial and ethnic origins
- Undergoing lumbar puncture for clinical or radiographic suspicion of leptomeningeal metastasis
- Provide study-specific informed consent
- Patients with unequivocal or suspicious MRI findings.
- Of those with a definitive diagnosis of LM (i.e. positive CSF cytology), 10 evaluable patients will be accrued.
You may not qualify if:
- Prior CSF fluid which identified malignant cells after 10 evaluable patients with positive CSF are accrued.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Cancer Institute (NCI)collaborator
- Biocept, Inc.collaborator
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin Kalinsky, MD
- Organization
- Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2016
First Posted
October 28, 2016
Study Start
February 6, 2017
Primary Completion
December 18, 2019
Study Completion
December 18, 2019
Last Updated
June 6, 2024
Results First Posted
June 6, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- "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)."
- Access Criteria
- "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."
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. "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)."