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Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00938756
Recruitment Status : Unknown
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 14, 2009
Last Update Posted : April 7, 2010
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal syndrome may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing carcinomatous meningitis in patients with cancer or meningeal syndrome.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Breast Cancer Metastatic Cancer Other: diagnostic laboratory biomarker analysis Other: immunoenzyme technique Procedure: magnetic resonance imaging Not Applicable

Detailed Description:



  • Evaluate the validity of determining CA 15-3 levels in the cerebrospinal fluid (CSF) using automated immuno-enzymatic methods.


  • Determine the sensitivity and specificity of these assays in assessing CA 15-3 in CSF.
  • Assess favorability of intrathecal production of CA 15-3.
  • Determine threshold interpretations of CA 15-3 levels in CSF.

OUTLINE: This is a multicenter study.

Within 15 days of suspected meningeal involvement, blood and cerebrospinal fluid samples are collected. Samples are examined by immunoenzyme assays. Patients with suspected cases of carcinomatous meningitis undergo cerebrospinal MRI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer
Study Start Date : April 2008
Estimated Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Primary Outcome Measures :
  1. CA 15-3 levels in cerebrospinal fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Meets 1 of the following criteria:

    • Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis
    • Other type of cancer with evidence suggestive of carcinomatous meningitis
    • Meningeal syndrome without context of cancer


  • No other prior cancers
  • Not pregnant or nursing


  • No prior intrathecal treatment
  • At least 4 weeks since prior interferon
  • No concurrent participation in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00938756

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Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Emilie Le Rhun    33-32-029-5959      
Sponsors and Collaborators
Centre Oscar Lambret
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Principal Investigator: Emilie Le Rhun Centre Oscar Lambret

Layout table for additonal information Identifier: NCT00938756     History of Changes
Other Study ID Numbers: CDR0000633542
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: April 7, 2010
Last Verified: April 2010

Keywords provided by National Cancer Institute (NCI):
leptomeningeal metastases
male breast cancer
stage IV breast cancer
tumors metastatic to brain
adult meningioma

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Nervous System Neoplasms
Central Nervous System Neoplasms
Meningeal Carcinomatosis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Meningeal Neoplasms