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Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome
Conditions
Brain and Central Nervous System Tumors - Breast Cancer - Metastatic Cancer
Conditions: official terms
Breast Neoplasms - Central Nervous System Neoplasms - Meningeal Carcinomatosis - Meningitis - Neoplasm Metastasis - Nervous System Neoplasms
Conditions: Keywords
leptomeningeal metastases, male breast cancer, stage IV breast cancer, tumors metastatic to brain, adult meningioma
Study Type
Interventional
Study Phase
N/A
Study Design
Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: diagnostic laboratory biomarker analysis
Type: Other
Name: immunoenzyme technique
Type: Other
Name: magnetic resonance imaging
Type: Procedure
Overall Status
Recruiting
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.
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Centre Oscar Lambret
Lille, France
Status: Recruiting
Contact: Emilie Le Rhun - 33-32-029-5959
Start Date
April 2008
Sponsors
Centre Oscar Lambret
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page