Back to resultsStudy of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome
Primary Purpose
Brain and Central Nervous System Tumors, Breast Cancer, Metastatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diagnostic laboratory biomarker analysis
immunoenzyme technique
magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain and Central Nervous System Tumors focused on measuring leptomeningeal metastases, male breast cancer, stage IV breast cancer, tumors metastatic to brain, adult meningioma
Eligibility 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
Sites / Locations
- Centre Oscar LambretRecruiting
Outcomes
Primary Outcome Measures
CA 15-3 levels in cerebrospinal fluid
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00938756
Brief Title
Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome
Official Title
Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Breast Cancer, Metastatic Cancer
Keywords
leptomeningeal metastases, male breast cancer, stage IV breast cancer, tumors metastatic to brain, adult meningioma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
immunoenzyme technique
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Primary Outcome Measure Information:
Title
CA 15-3 levels in cerebrospinal fluid
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Le Rhun
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Le Rhun
Phone
33-32-029-5959
12. IPD Sharing Statement
Learn more about this trial
Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome
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