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

Not Applicable

• Conditions: Brain and Central Nervous System Tumors; Breast Cancer; Metastatic Cancer

• Registration Number: NCT00938756
• Lead Sponsor: Centre Oscar Lambret

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.

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.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-05
• Study First Submitted: 2009-07-11
• Study First Submitted QC: 2009-07-11
• Study First Posted: 2009-07-14
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-06
• Last Update Posted: 2010-04-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CA 15-3 levels in cerebrospinal fluid

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France