NCT00938756

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
Last Updated

April 7, 2010

Status Verified

April 1, 2010

Enrollment Period

1.1 years

First QC Date

July 11, 2009

Last Update Submit

April 6, 2010

Conditions

Brain and Central Nervous System TumorsBreast CancerMetastatic Cancer

Keywords

leptomeningeal metastasesmale breast cancerstage IV breast cancertumors metastatic to brainadult meningioma

Outcome Measures

Primary Outcomes (1)

  • CA 15-3 levels in cerebrospinal fluid

Interventions

diagnostic laboratory biomarker analysisOTHER
immunoenzyme techniqueOTHER
magnetic resonance imagingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

MeSH Terms

Conditions

Central Nervous System NeoplasmsBreast NeoplasmsNeoplasm MetastasisMeningeal CarcinomatosisBreast Neoplasms, MaleBrain NeoplasmsMeningioma

Interventions

Immunoenzyme TechniquesMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsMeningeal NeoplasmsBrain DiseasesCentral Nervous System DiseasesNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

ImmunoassayImmunologic TechniquesInvestigative TechniquesImmunohistochemistryMolecular Probe TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Emilie Le Rhun

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2009

First Posted

July 14, 2009

Study Start

April 1, 2008

Primary Completion

May 1, 2009

Last Updated

April 7, 2010

Record last verified: 2010-04

Locations

FR(1)