Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00253669
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2005-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2005-11-11', 'studyFirstSubmitQcDate': '2005-11-11', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism', 'timeFrame': 'until dvt or death'}], 'secondaryOutcomes': [{'measure': 'ABO blood group association with venous thromboembolism (VTE) factor VIII activity and VTE as assessed by laboratory test result at study entry', 'timeFrame': 'on study'}]}, 'conditionsModule': {'keywords': ['thromboembolism', 'adult anaplastic astrocytoma', 'adult anaplastic oligodendroglioma', 'adult glioblastoma', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Thromboembolism']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about the risk factors for developing blood clots may help doctors plan better treatment for gliomas.\n\nPURPOSE: This clinical trial is studying risk factors for developing blood clots in patients who are undergoing cancer treatment for newly diagnosed gliomas.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the overall hazard rate of first venous thromboembolism per person-year of follow-up in patients undergoing antineoplastic therapy for newly diagnosed high-grade gliomas.\n* Correlate ABO blood type with incidence of venous thromboembolism in these patients.\n* Correlate factor VIII level with incidence of venous thromboembolism in these patients.\n\nSecondary\n\n* Determine the overall and individual incidence rate of thromboembolism in these patients.\n* Correlate clinical variables, such as type of antineoplastic treatments, Karnofsky performance status, and type of tumor, with incidence of venous thromboembolism in these patients.\n* Correlate demographic factors, such as age, with incidence of venous thromboembolism in these patients.\n\nOUTLINE: This is a pilot, multicenter study.\n\nPatients undergo blood collection for blood typing (if not already obtained) and factor VIII and C-reactive protein levels at baseline. Patients are followed to obtain information on their Karnofsky performance status, treatment they receive for their brain tumor, and occurrence of any thrombotic events (e.g., pulmonary embolism or deep-vein thrombosis). Patients are followed every 28 days until the development of thrombotic events, after which they are followed every 2 months for survival.\n\nPROJECTED ACCRUAL: A total of 107 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'outpatient clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed newly diagnosed malignant brain tumor\n\n * Supratentorial grade III or IV astrocytoma of 1 of the following types:\n\n * Anaplastic astrocytoma\n * Anaplastic oligodendroglioma\n * Glioblastoma multiforme\n* No prior thrombotic event\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* Karnofsky 60-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior immunotherapy or biologic agents, including immunotoxins, immunoconjugates, antisense therapy, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphocyte-activated killer cells, or gene therapy, for the brain tumor\n\nChemotherapy\n\n* No prior chemotherapy for the brain tumor except polifeprosan 20 with carmustine implant (Gliadel wafer)\n\nEndocrine therapy\n\n* No prior hormonal therapy for the brain tumor except glucocorticoids\n\nRadiotherapy\n\n* No prior radiotherapy for the brain tumor\n* No prior cranial irradiation\n\nOther\n\n* No concurrent chronic anticoagulation therapy'}, 'identificationModule': {'nctId': 'NCT00253669', 'briefTitle': 'Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade Gliomas', 'orgStudyIdInfo': {'id': 'NABTT-0307'}, 'secondaryIdInfos': [{'id': 'U01CA062475', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062475', 'type': 'NIH'}, {'id': 'CDR0000441111'}, {'id': 'JHOC-NABTT-0307'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'physiologic testing', 'type': 'OTHER'}, {'name': 'management of therapy complications', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute at University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Josephine Ford Cancer Center at Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '27157-1096', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Michael B. Streiff, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, {'name': 'Stuart A. Grossman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, {'name': 'Larry Kleinberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'North American Brain Tumor Consortium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}