Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 4:22 AM
Study NCT ID:
NCT00908960
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2009-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jzwicker@bidmc.harvard.edu', 'phone': '617-667-9299', 'title': 'Jeffrey Zwicker, MD', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Assessed during the 60 day therapy', 'eventGroups': [{'id': 'EG000', 'title': 'High TFMP: Enoxaparin', 'description': 'Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).\n\nOnly patients with high TFMP status at baseline were randomized to treatment or observation.', 'otherNumAtRisk': 23, 'otherNumAffected': 6, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.', 'otherNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.', 'otherNumAtRisk': 32, 'otherNumAffected': 7, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspnea', 'notes': 'A subject with lung cancer on the observation arm experienced shortness of breath while on trial. Another study subject with pancreatic cancer on the observation arm died following rapidly progressive shortness of breath and hypoxia at nursing home.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Disease progression', 'notes': 'These subjects had disease progression: 3 Lung cancer on observation; 1 pancreatic cancer on observation; 1 pancreatic cancer on lovenox and another lung cancer on lovenox.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection', 'notes': 'A pancreatic cancer subject on observation arm died following a blood infection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'notes': 'Subject with lung cancer on lovenox and was found with low platelets. Another subject with colon cancer on observation was also found with low platelets.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alkaline Phosphotase and aspartate aminotransferase', 'notes': 'Subject with pancreatic cancer and on lovenox was hospitalized for a decreased urine output, obstructive liver function tests, and ankle edema.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphatics', 'notes': 'Subject with lung cancer and on lovenox was hospitalized with increased swelling and discomfort over left side of neck.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'pneumonia and anemia', 'notes': 'subject with pancreatic cancer on lovenox arm was hospitalized for pneumonia and anemia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'elevated troponin', 'notes': 'A pancreatic cancer subject on observation arm with elevated troponin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GI-Hemorrhage', 'notes': 'Study subject with pancreatic cancer on the observation arm died following an gastrointestinal bleed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '2-Month Cumulative Incidence of VTE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High TFMP: Enoxaparin', 'description': 'Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'OG001', 'title': 'High TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'OG002', 'title': 'Low TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16.6'}, {'value': '27.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '55.1'}, {'value': '7.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '17.1'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '1.03', 'ciUpperLimit': '43.17', 'statisticalMethod': 'Fine and Gray regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessment with lower extremity ultrasound occured at day 60/ month 2', 'description': '2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis dataset is comprised of all evaluable patients.'}, {'type': 'SECONDARY', 'title': 'Incidence of Major Hemorrhage Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High TFMP: Enoxaparin', 'description': 'Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'OG001', 'title': 'High TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'OG002', 'title': 'Low TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed during the 60 day therapy', 'description': 'Incidence is the number of patients experiencing at least one major hemorrhage events as defined according to International Society on Thrombosis and Haemostasis (ISTH) guidelines. (Schulman and Kearon 2005)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis dataset is comprised of evaluable patients.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High TFMP: Enoxaparin', 'description': 'Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'OG001', 'title': 'High TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'OG002', 'title': 'Low TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '30'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '18.2'}, {'value': '17.3', 'groupId': 'OG002', 'lowerLimit': '10.3', 'upperLimit': '24.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed up to approximately 30 months', 'description': 'Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis dataset is comprised of all evaluable patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High TFMP: Enoxaparin', 'description': 'Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'FG001', 'title': 'High TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'FG002', 'title': 'Low TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'Evaluable', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Presence VTE dx or Absent VTE eval', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High TFMP: Enoxaparin', 'description': 'Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).\n\nOnly patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'BG001', 'title': 'High TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'id': 'BG002', 'title': 'Low TFMP: Observation', 'description': 'Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '64.0', 'spread': '11.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis dataset is comprised of all evaluable patients.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-22', 'studyFirstSubmitDate': '2009-05-26', 'resultsFirstSubmitDate': '2013-07-22', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-22', 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-Month Cumulative Incidence of VTE', 'timeFrame': 'Assessment with lower extremity ultrasound occured at day 60/ month 2', 'description': '2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Major Hemorrhage Events', 'timeFrame': 'Assessed during the 60 day therapy', 'description': 'Incidence is the number of patients experiencing at least one major hemorrhage events as defined according to International Society on Thrombosis and Haemostasis (ISTH) guidelines. (Schulman and Kearon 2005)'}, {'measure': 'Overall Survival', 'timeFrame': 'Assessed up to approximately 30 months', 'description': 'Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['enoxaparin'], 'conditions': ['Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '23240761', 'type': 'RESULT', 'citation': 'Zwicker JI, Liebman HA, Bauer KA, Caughey T, Campigotto F, Rosovsky R, Mantha S, Kessler CM, Eneman J, Raghavan V, Lenz HJ, Bullock A, Buchbinder E, Neuberg D, Furie B. Prediction and prevention of thromboembolic events with enoxaparin in cancer patients with elevated tissue factor-bearing microparticles: a randomized-controlled phase II trial (the Microtec study). Br J Haematol. 2013 Feb;160(4):530-7. doi: 10.1111/bjh.12163. Epub 2012 Dec 13.'}, {'pmid': '33337539', 'type': 'DERIVED', 'citation': 'Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.'}]}, 'descriptionModule': {'briefSummary': 'Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots in patients after abdominal or orthopedic surgery and in patients who suffer from a severe medical illness. Based on these studies, we are investigating to see if it prevents thrombosis in people with certain types of cancer.', 'detailedDescription': 'The study was a randomized phase II trial to evaluate the cumulative incidence of VTE in cancer outpatients. At baseline, measurement of tissue factor-bearing microparticles (TFMP) was performed by impedance-based flow cytometry based on established methods. (Zwicker et al, 2009) Patients were classified as having high or low TFMP levels based on a reference repository of plasmas from sixty cancer patients. The top tercile of tissue factor-bearing microparticle concentrations from the reference specimens (3.5 x 104 microparticles/µl) was considered a cutoff for "high" and corresponds with previously described "detectable" levels. Patients with high levels were randomized (2:1) to enoxaparin 40 mg subcutaneously once daily or observation. Randomization was stratified based on cancer diagnosis. Low TFMP patients were observed without anticoagulation. Both the treating physicians and patients were blinded to microparticle status in the observation arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative therapies do not exist. Eligible malignancies include:\n\n * Adenocarcinoma of the pancreas (locally advanced or metastatic)\n * Colorectal (stage IV)\n * Non-small cell lung (unresectable stage III or IV)\n * Relapsed ovarian or stage IV\n * Surgically unresectable or metastatic gastric adenocarcinoma\n* First or second line therapy (within 4 weeks of initiating therapy).\n* Minimum age 18 years\n* Life expectancy of greater than 6 months\n* ECOG Performance Status 0, 1, or 2 (Karnofsky 60% or greater).\n* Participants must have normal organ and marrow function as outlined in the protocol.\n\nExclusion Criteria:\n\n* Participants may not be receiving any other study agents.\n* Known brain metastases should be excluded from this clinical trial because of their poor prognosis and higher potential for intracranial hemorrhage.\n* Prior history of documented venous thromboembolic event or pulmonary embolism within the last 5 years years (excluding central line associated events whereby patients completed anticoagulation \\> 3 months previously)\n* Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)\n* Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 5 years\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or heparin.\n* History of heparin-induced thrombocytopenia\n* Presence of coagulopathy (PT or PTT\\> 1.5 x upper limit of normal)\n* Familial bleeding diathesis\n* Known diagnosis of disseminated intravascular coagulation\n* Currently receiving anticoagulant therapy\n* Current use of aspirin (\\>81mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox), or regular use of non-steroidal anti-inflammatory agents more than twice weekly. Maximum dose of ibuprofen is 400mg no more than twice per week.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.'}, 'identificationModule': {'nctId': 'NCT00908960', 'acronym': 'MicroTEC', 'briefTitle': 'Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles', 'orgStudyIdInfo': {'id': '08-378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High TFMP: Enoxaparin', 'description': 'Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).Only patients with high TFMP status at baseline were randomized to treatment or observation.', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'NO_INTERVENTION', 'label': 'High TFMP: Observation', 'description': 'Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.'}, {'type': 'NO_INTERVENTION', 'label': 'Low TFMP: Observation', 'description': 'Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.'}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'armGroupLabels': ['High TFMP: Enoxaparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California-Keck School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01923', 'city': 'Danvers', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mass General/North Shore Cancer Center', 'geoPoint': {'lat': 42.57509, 'lon': -70.93005}}], 'overallOfficials': [{'name': 'Jeffrey Zwicker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'North Shore Medical Center', 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'VA Boston Healthcare System', 'class': 'FED'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Jeffrey Zwicker, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}