Brain and Central Nervous System TumorsNCT00938756
Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome
A study testing diagnostic laboratory biomarker analysis, immunoenzyme technique and magnetic resonance imaging in people with Brain and Central Nervous System Tumors and Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Breast Cancer, Metastatic Cancer
- What is being tested?
- diagnostic laboratory biomarker analysis, immunoenzyme technique and magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Oscar Lambret
Lille, 59020
Emilie Le Rhun, 33-32-029-5959
About this study
Official title: Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer
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.
- Being tested
- diagnostic laboratory biomarker analysis, immunoenzyme technique, magnetic resonance imaging
- Keywords
- leptomeningeal metastases, male breast cancer, stage IV breast cancer, tumors metastatic to brain, adult meningioma
- Medical subject headings
- Central Nervous System Neoplasms, Breast Neoplasms, Neoplasm Metastasis, Meningeal Carcinomatosis, Breast Neoplasms, Male, Brain Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic laboratory biomarker analysisOther
immunoenzyme techniqueOther
magnetic resonance imagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
CA 15-3 levels in cerebrospinal fluid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startApr 2008
- Primary completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Investigators
- Emilie Le Rhun, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938756
- Sponsor's protocol ID
- CDR0000633542
- Other IDs
- COL-MENINCA, COL-IDRCB-2008-A00185-50, COL-0801, INCA-RECF0807
- Status last verified
- Apr 2010
- First submitted
- 11 Jul 2009
- Last updated
- 7 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer
- ClinicalTrials.gov ID
- NCT00938756
- Acronym / sponsor ID
- CDR0000633542
- Keywords
- leptomeningeal metastases, male breast cancer, stage IV breast cancer, tumors metastatic to brain, adult meningioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2009 (estimated)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic laboratory biomarker analysis | Other | – |
| immunoenzyme technique | Other | – |
| magnetic resonance imaging | Procedure or surgery | – |
Primary outcome
CA 15-3 levels in cerebrospinal fluid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Le Rhun principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic laboratory biomarker analysis, immunoenzyme technique and magnetic resonance imaging in people with Brain and Central Nervous System Tumors and Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CA 15-3 levels in cerebrospinal fluid. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2010.