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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00938756
First received: July 11, 2009
Last updated: April 6, 2010
Last verified: April 2010
  Purpose

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: 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 [ Designated as safety issue: No ]

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

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • No other prior cancers
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • 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 ClinicalTrials.gov identifier: NCT00938756

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00938756     History of Changes
Other Study ID Numbers: CDR0000633542, COL-MENINCA, COL-IDRCB-2008-A00185-50, COL-0801, INCA-RECF0807
Study First Received: July 11, 2009
Last Updated: April 6, 2010
Health Authority: Unspecified

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
Meningitis
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Meningeal Carcinomatosis
Neoplasms by Site
Breast Diseases
Skin Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Meningeal Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014