Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-01 @ 1:14 PM
Study NCT ID:
NCT02739867
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor-educated Platelets in Venous Thromboembolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Platelet pellet, EDTA plasma, citrated plasma, and cell-free DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 476}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2016-04-12', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any solid or hematological cancer', 'timeFrame': 'Up to one year following venous thromboembolism', 'description': 'Adjudicated diagnosis of solid or haematological cancer which is confirmed by histology or cytology, or is unequivocally diagnosed by either imaging or tumour markers'}], 'secondaryOutcomes': [{'measure': 'Early-stage solid cancer', 'timeFrame': 'Up to one year following venous thromboembolism', 'description': 'Early-stage solid cancer, defined as stage I or II solid cancer according to the American Joint Commissee on Cancer criteria.'}, {'measure': 'Recurrent venous thromboembolism', 'timeFrame': 'Up to one year following venous thromboembolism', 'description': 'Adjudicated recurrent VTE (see full definition in protocol)'}, {'measure': 'Major bleeding', 'timeFrame': 'Up to one year following venous thromboembolism', 'description': 'Adjudicated major bleeding according to the International Society on Thrombosis and Haemostasis criteria'}, {'measure': 'Clinically relevant non-major bleeding', 'timeFrame': 'Up to one year following venous thromboembolism', 'description': 'Adjudicated clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria'}, {'measure': 'Composite of major bleeding and clinically relevant non-major bleeding', 'timeFrame': 'Up to one year following venous thromboembolism'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to one year following venous thromboembolism'}, {'measure': 'Cancer-related mortality', 'timeFrame': 'Up to one year following venous thromboembolism'}, {'measure': 'Solid cancer', 'timeFrame': 'Up to one year following venous thromboembolism'}, {'measure': 'Hematological cancer', 'timeFrame': 'Up to one year following venous thromboembolism'}, {'measure': 'Composite of solid cancer and lymphoma', 'timeFrame': 'Up to one year following venous thromboembolism'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['occult cancer', 'venous thromboembolism', 'tumor-educated platelets', 'platelet RNA profiling', 'early diagnosis', 'screening'], 'conditions': ['Neoplasms', 'Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '26525104', 'type': 'BACKGROUND', 'citation': 'Best MG, Sol N, Kooi I, Tannous J, Westerman BA, Rustenburg F, Schellen P, Verschueren H, Post E, Koster J, Ylstra B, Ameziane N, Dorsman J, Smit EF, Verheul HM, Noske DP, Reijneveld JC, Nilsson RJA, Tannous BA, Wesseling P, Wurdinger T. RNA-Seq of Tumor-Educated Platelets Enables Blood-Based Pan-Cancer, Multiclass, and Molecular Pathway Cancer Diagnostics. Cancer Cell. 2015 Nov 9;28(5):666-676. doi: 10.1016/j.ccell.2015.09.018. Epub 2015 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Among patients with a first episode of unprovoked venous thromboembolism (VTE), the contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of platelets is a promising, highly accurate biomarker for cancer detection, but its clinical utility in patients with unprovoked VTE is unknown. The objective of the present study is to evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients of 40 years or older with a first episode of objectively confirmed, symptomatic unprovoked distal or proximal deep vein thrombosis or pulmonary embolism.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First episode of objectively confirmed, symptomatic, unprovoked symptomatic pulmonary embolism and/or distal or proximal deep vein thrombosis of the leg\n* Age 40 years or older\n* Written informed consent\n\nExclusion Criteria:\n\n* known malignant disease prior to VTE defined as a cancer diagnosis or cancer treatment within the past 5 years (of note: suspected but unconfirmed cancer at diagnosis of VTE is allowed);\n* trauma or fracture of the leg, surgical procedures, general anesthesia, or immobilization greater than 3 days within previous 3 months;\n* previous unprovoked venous thromboembolism;\n* known hereditary or acquired thrombophilia;\n* current pregnancy or puerperium (up to 3 months postpartum);\n* current estrogen therapy.\n* Greater than 10 days after VTE diagnosis;\n* Inability for blood withdrawal at baseline;\n* Inability or refusal to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT02739867', 'briefTitle': 'Tumor-educated Platelets in Venous Thromboembolism', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Platelet RNA Profiling to Detect Occult Cancer in Patients With Unprovoked Venous Thromboembolism', 'orgStudyIdInfo': {'id': 'PLATO-VTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unprovoked VTE', 'description': 'Patients aged 40 years or older with a first episode of objectively confirmed, symptomatic, unprovoked deep vein thrombosis of the leg (distal or proximal) or pulmonary embolism'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Ottawa', 'country': 'Canada', 'facility': 'Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Dresden University Clinic', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Bologna University Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Chieti', 'country': 'Italy', 'facility': "Gabriele D'Annunzio University", 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'University of Padua', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'University of Insubria', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Almere Stad', 'country': 'Netherlands', 'facility': 'Flevoziekenhuis', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Slotervaartziekenhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU medical center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Hilversum', 'country': 'Netherlands', 'facility': 'Tergooiziekenhuizen', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Harry Büller, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Vascular Medicine', 'investigatorFullName': 'Harry R. Buller', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}