Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome - Full Text View

Sponsor:	Centre Oscar Lambret
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00938756

Purpose

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.

Condition	Intervention
Brain and Central Nervous System Tumors Breast Cancer Metastatic Cancer	Other: diagnostic laboratory biomarker analysis Other: immunoenzyme technique Procedure: magnetic resonance imaging

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans Meningitis

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

CA 15-3 levels in cerebrospinal fluid [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	April 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938756

Locations

France
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Contact: Emilie Le Rhun 33-32-029-5959

Sponsors and Collaborators

Centre Oscar Lambret

Investigators

Principal Investigator:

Emilie Le Rhun

Centre Oscar Lambret

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00938756 History of Changes
Other Study ID Numbers:	CDR0000633542, COL-MENINCA, COL-IDRCB-2008-A00185-50, COL-0801, INCA-RECF0807
Study First Received:	July 11, 2009
Last Updated:	April 6, 2010
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

leptomeningeal metastases
male breast cancer
stage IV breast cancer
tumors metastatic to brain
adult meningioma

Additional relevant MeSH terms:

Breast Neoplasms
Meningitis
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Meningeal Carcinomatosis
Neoplasms by Site

Breast Diseases
Skin Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Meningeal Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012