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

Centre Oscar Lambret

Status: Unknown

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

Treatments: Other: diagnostic laboratory biomarker analysis; Procedure: magnetic resonance imaging; Other: immunoenzyme technique

Study type: Interventional

Funder types: Other

Identifiers

NCT00938756

INCA-RECF0807

COL-MENINCA

COL-0801

COL-IDRCB-2008-A00185-50

CDR0000633542

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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