Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome

Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00938756

Enrollment

Registered

2009-07-14

Start date

2008-04-30

Completion date

Unknown

Last updated

2010-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERdiagnostic laboratory biomarker analysis

OTHERimmunoenzyme technique

PROCEDUREmagnetic resonance imaging

Study design

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
CA 15-3 levels in cerebrospinal fluid	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026