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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D055756', 'term': 'Meningeal Carcinomatosis'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2010-04-06', 'studyFirstSubmitDate': '2009-07-11', 'studyFirstSubmitQcDate': '2009-07-11', 'lastUpdatePostDateStruct': {'date': '2010-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CA 15-3 levels in cerebrospinal fluid'}]}, 'conditionsModule': {'keywords': ['leptomeningeal metastases', 'male breast cancer', 'stage IV breast cancer', 'tumors metastatic to brain', 'adult meningioma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Breast Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal syndrome may help doctors identify biomarkers related to cancer.\n\nPURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing carcinomatous meningitis in patients with cancer or meningeal syndrome.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the validity of determining CA 15-3 levels in the cerebrospinal fluid (CSF) using automated immuno-enzymatic methods.\n\nSecondary\n\n* Determine the sensitivity and specificity of these assays in assessing CA 15-3 in CSF.\n* Assess favorability of intrathecal production of CA 15-3.\n* Determine threshold interpretations of CA 15-3 levels in CSF.\n\nOUTLINE: This is a multicenter study.\n\nWithin 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis\n * Other type of cancer with evidence suggestive of carcinomatous meningitis\n * Meningeal syndrome without context of cancer\n\nPATIENT CHARACTERISTICS:\n\n* No other prior cancers\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior intrathecal treatment\n* At least 4 weeks since prior interferon\n* No concurrent participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00938756', 'briefTitle': 'Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000633542'}, 'secondaryIdInfos': [{'id': 'COL-MENINCA'}, {'id': 'COL-IDRCB-2008-A00185-50'}, {'id': 'COL-0801'}, {'id': 'INCA-RECF0807'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'diagnostic laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'immunoenzyme technique', 'type': 'OTHER'}, {'name': 'magnetic resonance imaging', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Le Rhun', 'role': 'CONTACT', 'phone': '33-32-029-5959'}], 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Emilie Le Rhun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}}}}