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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00938756
• Other study ID #: CDR0000633542
• Secondary ID: COL-MENINCACOL-I
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2009
• Last updated: April 6, 2010
• Start date: April 2008

Study information

• Verified date: April 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Breast Cancer
• Breast Neoplasms
• Central Nervous System Neoplasms
• Meningeal Carcinomatosis
• Meningitis
• Metastatic Cancer
• Neoplasm Metastasis
• Nervous System Neoplasms

Intervention

Other:
• diagnostic laboratory biomarker analysis

• immunoenzyme technique

Procedure:
• magnetic resonance imaging

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CA 15-3 levels in cerebrospinal fluid			No