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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 11, 2009
Last updated: April 6, 2010
Last verified: April 2010

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 Intervention
Brain and Central Nervous System Tumors Breast Cancer Metastatic Cancer Other: diagnostic laboratory biomarker analysis Other: immunoenzyme technique Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 80
Study Start Date: April 2008
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00938756

Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Emilie Le Rhun    33-32-029-5959      
Sponsors and Collaborators
Centre Oscar Lambret
Principal Investigator: Emilie Le Rhun Centre Oscar Lambret
  More Information Identifier: NCT00938756     History of Changes
Other Study ID Numbers: CDR0000633542
Study First Received: July 11, 2009
Last Updated: April 6, 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:
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 processed this record on September 21, 2017