NCT00938756

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

Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain and Central Nervous System Tumors
• Breast Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
OTHER	diagnostic laboratory biomarker analysis
OTHER	immunoenzyme technique
PROCEDURE	magnetic resonance imaging

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-05-01
• First posted: 2009-07-14
• Last updated: 2010-04-07

Locations

1 site across 1 country: France