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Trial Title:
Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome
NCT ID:
NCT00938756
Condition:
Brain and Central Nervous System Tumors
Breast Cancer
Metastatic Cancer
Conditions: Official terms:
Breast Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Meningeal Carcinomatosis
Meningitis
Conditions: Keywords:
leptomeningeal metastases
male breast cancer
stage IV breast cancer
tumors metastatic to brain
adult meningioma
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
diagnostic laboratory biomarker analysis
Intervention type:
Other
Intervention name:
immunoenzyme technique
Intervention type:
Procedure
Intervention name:
magnetic resonance imaging
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Zip:
59020
Country:
France
Status:
Recruiting
Contact:
Last name:
Emilie Le Rhun
Phone:
33-32-029-5959
Start date:
April 2008
Lead sponsor:
Agency:
Centre Oscar Lambret
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00938756