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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

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