Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 2:53 PM
Study NCT ID:
NCT00938756
Status:
UNKNOWN
Last Update Posted:
2010-04-07
First Post:
2009-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome
Sponsor:
Centre Oscar Lambret
Organization:
Study Overview
Official Title:
Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2010-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: