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Status unknownNCT00938756Updated Apr 7, 2010

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

An interventional study of diagnostic laboratory biomarker analysis and immunoenzyme technique in Brain and Central Nervous System Tumors, Breast Cancer and Metastatic Cancer, sponsored by Centre Oscar Lambret. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-07.

Sponsored by Centre Oscar Lambret · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Apr 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Central Nervous System Neoplasms

684 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.

This study's planned enrollment of 80 is above the median of 35 across 474 interventional studies indexed under Central Nervous System Neoplasms.

Browse Central Nervous System Neoplasms studies →

Lead sponsor

Centre Oscar Lambret is the lead sponsor of 130 studies on the registry; 13 are open to participants now.

Browse Centre Oscar Lambret studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Masking
None (open label)
Enrollment
80 participants (estimated)

Interventions

  • Otherdiagnostic laboratory biomarker analysis
  • Otherimmunoenzyme technique
  • Proceduremagnetic resonance imaging
06

What researchers measure

Primary outcomes

  1. CA 15-3 levels in cerebrospinal fluid

07

Study locations

1 of 1 sites recruiting
  • Centre Oscar Lambret
    Lille, 59020, France
    • Emilie Le Rhun · Contact · 33-32-029-5959
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2008 and a primary completion of May 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2009
First posted
Jul 14, 2009
Start
Apr 2008
Primary completionEst.
May 2009
Last update
Apr 7, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00938756
Lead sponsor
Centre Oscar Lambret
First posted
Jul 14, 2009
Start date
Apr 2008
Primary completion
May 2009 (estimated)
Last update
Apr 7, 2010

Study contacts

Emilie Le Rhun
principal investigator · Centre Oscar Lambret
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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