Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-15 @ 2:49 AM
Study NCT ID:
NCT03134820
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2017-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 352}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence thromboembolisms', 'timeFrame': '3 months', 'description': 'Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression'}, {'measure': 'Recurrence thromboembolisms', 'timeFrame': '6 months', 'description': 'Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression'}], 'secondaryOutcomes': [{'measure': 'Hemorrhagic events', 'timeFrame': '6 months', 'description': 'Hemorrhagic events due to LMWH treatment'}, {'measure': 'Thromboembolic event attributable death', 'timeFrame': '6 months', 'description': 'Death related to embolic event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low molecular weight heparins', 'Procoagulants', 'Phospholipid-dependent Microparticles'], 'conditions': ['Venous Thromboembolism', 'Pulmonary Thromboembolisms', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Cancer is the most important acquired risk factor of thromboembolisms. More than 20% of all episodes of venous thromboembolism (VT) or pulmonary thromboembolisms (PT) are cancer related. Cancer patients with VT or PT are treated with low molecular weight heparins (LMWH) during at least 3 months, but nowadays the duration of treatment is not accurately determined.\n\nThe D-Dimer determination has been used like recurrence predictors after LMWH treatment suspension, but in cancer patients the useful is limited. Phospholipid-dependent microparticles could been used like recurrence predictors in cancer patients and tailored the duration of LMWH treatment for each patient.', 'detailedDescription': 'We are carrying out a study in Cancer-associated-thromboembolism patients in order to decide the suitable anticoagulation time. A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn. Patients are being followed after LMWH withdrawal until 6 months. Blood samples are being taken at baseline (LMWH withdrawal), 3 weeks and 3 months after. We will look for association between several biomarkers and venous thromboembolism recurrences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (PT) or venous thromboembolism (VT) , in treatment with low molecular weight heparin (LMWH).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (PT) or venous thromboembolism (VT) , in treatment with low molecular weight heparin (LMWH).\n* Patients treated with LMWH since cancer diagnostic.\n* Signed informed consent sheet\n\nExclusion Criteria:\n\n* Patients with life expectancy lower than 6 months\n* Pregnancy woman\n* Patients with cerebral metastasis'}, 'identificationModule': {'nctId': 'NCT03134820', 'briefTitle': 'Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Delos Clinical'}, 'officialTitle': 'Time of Treatment With Low Molecular Weight Heparins in Cancer Patients With Thromboembolic Disease. Procoagulant Role of Phospholipid-dependent Microparticles.', 'orgStudyIdInfo': {'id': 'Hispalis study'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Remedios Otero Candelera, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Virgen del Rocío IBIS'}, {'name': 'Teresa Elias, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospitales Universitarios Virgen del Rocío'}, {'name': 'Isabel Blasco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen Macarena'}, {'name': 'Maria Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Valme'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delos Clinical', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Ph D', 'investigatorFullName': 'Remedios Otero Candelera', 'investigatorAffiliation': 'Hospitales Universitarios Virgen del Rocío'}}}}