Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT01132833
Status:
COMPLETED
Last Update Posted:
2016-08-22
First Post:
2010-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004797', 'term': 'Enzyme-Linked Immunosorbent Assay'}], 'ancestors': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007163', 'term': 'Immunosorbent Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-18', 'studyFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2010-05-27', 'lastUpdatePostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of circulating tissue factor (TF)', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Alteration in coagulation parameters', 'timeFrame': '5 years'}, {'measure': 'Correlation of TF with markers of coagulation activation and endothelial activation', 'timeFrame': '5 years'}, {'measure': 'Incidence of venous thromboembolism', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thromboembolism', 'stage I multiple myeloma', 'stage II multiple myeloma', 'stage III multiple myeloma'], 'conditions': ['Multiple Myeloma', 'Plasma Cell Neoplasm', 'Thromboembolism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.unclineberger.org', 'label': 'web address for Lineberger Comprehensive Cancer Center, UNC'}, {'url': 'http://www.cancer.gov', 'label': 'web address for the National Cancer Institute (NCI)'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how patients respond to treatment.\n\nPURPOSE: This research study is studying biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To measure levels of circulating tissue factor (TF) in patients with newly diagnosed multiple myeloma at several time points before, during, and after the administration of chemotherapy and/or antiangiogenic agents.\n\nSecondary\n\n* To measure the correlation of TF with two markers of coagulation activation (i.e., D-dimer, thrombin-antithrombin \\[TAT\\] complexes) and two markers of endothelial activation (i.e., soluble E-selectin, soluble thrombomodulin) in these patients.\n* To measure and compare (descriptively) our microparticle-associated TF procoagulant activity assay with two other assays using samples from these patients.\n\nOUTLINE: Patients undergo blood sample collection at baseline and then periodically during treatment. Circulating tissue factor (TF) activity levels and coagulation and endothelial activation (by ELISA) are measured. Medical charts are reviewed for sociodemographic and medical information.\n\nAfter completion of study, patients are followed up for 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed multiple Multiple Myeloma', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Newly diagnosed; relapsed, or refractory multiple myeloma\n\nPATIENT CHARACTERISTICS:\n\n* Central venous access devices allowed\n* Recruited by the Division of Hematology/Oncology and the Lineberger Comprehensive Cancer Center at the University of North Carolina\n* No history of venous thromboembolism\n* No hospitalization for \\> 2 days within the past month\n* Not pregnant\n* No patient who refuses or is deemed unsuitable for chemotherapy\n\nPRIOR CONCURRENT THERAPY:\n\n* No surgery within the past month\n\n * Bone marrow biopsies, central venous line placement and diagnostic biopsies by surgery or fine-needle aspiration allowed\n* \\* No concurrent anticoagulation therapy\n\n * Concurrent antiplatelet agents, such as aspirin and/or clopidogrel, allowed'}, 'identificationModule': {'nctId': 'NCT01132833', 'briefTitle': 'Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.', 'orgStudyIdInfo': {'id': 'LCCC 0802'}, 'secondaryIdInfos': [{'id': 'P30CA016086', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016086', 'type': 'NIH'}, {'id': 'CDR0000674053', 'type': 'OTHER', 'domain': 'PDQ number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'enzyme-linked immunosorbent assay', 'type': 'OTHER', 'description': 'Measurement of markers of coagulation and endothelial activation'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'The PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage'}, {'name': 'medical chart review', 'type': 'OTHER', 'description': "The patient's clinical course with respect to development of venous thromboembolism and response to treatment will be monitored for a total of 3 months from enrollment."}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Nigel Mackman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}