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


N/A
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Breast Cancer, Metastatic Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

CA 15-3 levels in cerebrospinal fluid

Safety Issue:

No

Principal Investigator

Emilie Le Rhun

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret

Authority:

Unspecified

Study ID:

CDR0000633542

NCT ID:

NCT00938756

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Breast Cancer
  • Metastatic Cancer
  • leptomeningeal metastases
  • male breast cancer
  • stage IV breast cancer
  • tumors metastatic to brain
  • adult meningioma
  • Breast Neoplasms
  • Meningitis
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Meningeal Carcinomatosis

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