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

NCT ID: NCT00938756

Last Updated: 2010-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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

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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

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Brain and Central Nervous System Tumors Breast Cancer Metastatic Cancer

Study Design

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Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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diagnostic laboratory biomarker analysis

Intervention Type OTHER

immunoenzyme technique

Intervention Type OTHER

magnetic resonance imaging

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Oscar Lambret

OTHER

Sponsor Role lead

Principal Investigators

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Emilie Le Rhun

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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Centre Oscar Lambret

Lille, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Emilie Le Rhun

Role: primary

33-32-029-5959

Other Identifiers

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COL-MENINCA

Identifier Type: -

Identifier Source: secondary_id

COL-IDRCB-2008-A00185-50

Identifier Type: -

Identifier Source: secondary_id

COL-0801

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0807

Identifier Type: -

Identifier Source: secondary_id

CDR0000633542

Identifier Type: -

Identifier Source: org_study_id

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