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NCT02948751 · ClinicalTrials.gov registry record
Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer
A clinical trial, sponsored by Columbia University.
- Completed
- Registry status
- 14
- Enrollment target
NCT02948751: Completed study, sponsored by Columbia University.
NCT02948751 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02948751 has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
Total number of participants with leptomeningeal metastasis detected (ER status)
Interventions
- DEVICE OncoCEE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2019-12-18 |
What the finished NCT02948751 record still lists
NCT02948751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which OncoCEE is the first listed.
NCT02948751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02948751 about?
NCT02948751 is a clinical study titled "Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer". 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 w...
What is the current status of trial NCT02948751?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2017-02-06. Estimated completion is 2019-12-18.
What interventions are being tested in trial NCT02948751?
The interventions under investigation include: OncoCEE (DEVICE).
Who is sponsoring clinical trial NCT02948751?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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