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Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer

NCT02948751 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-06-06

Study results available
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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.

Conditions

Interventions

DEVICE

OncoCEE

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).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Biocept, Inc.

    collaborator INDUSTRY

  • Columbia University

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2019-12-18
Completion
2019-12-18

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02948751 on ClinicalTrials.gov