Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT02785757
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2016-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer-related Thromboembolic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-02-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-05-27', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thrombin generation assay results', 'timeFrame': '7 months'}], 'secondaryOutcomes': [{'measure': 'Clotting activation markers: thrombin-antithrombin complexes (TAT)', 'timeFrame': '7 months'}, {'measure': 'Clotting activation markers: prothrombin fragment F1+2', 'timeFrame': '7 months'}, {'measure': 'Clotting activation markers: D-dimer', 'timeFrame': '7 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma', 'venous thromboembolism', 'thrombin generation assay'], 'conditions': ['Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.\n\nThe study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk\n\nThe secondary objectives are:\n\n* To define the limits of TGT parameters that indicate thrombosis risk in cancer patients\n* To evaluate values of other clotting activation markers in patients with cancer\n\nPatients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.\n\nPatients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.\n\nThe study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy\n* Subjects having signed Informed Consent prior to initiation of any study procedure\n* Covered by a Health System\n\nExclusion Criteria:\n\n* Known bleeding or thrombophilia disorders\n* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3\n* Patient immobilized\n* Confirmed venous thromboembolism in the last 12 months\n* Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention\n* Anticoagulant therapy at the moment of first sampling (at least one day off for Heparines and DOAc; at least 5 days off for VKA is needed)\n* Antiplatelet therapy at the moment of first sampling (only if PRP TGA can be performed at site)\n* Severe hepatic insufficiency\n* Life expectancy of less than 3 months\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02785757', 'acronym': 'PROSPECT', 'briefTitle': 'Cancer-related Thromboembolic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?', 'orgStudyIdInfo': {'id': '2012.788'}, 'secondaryIdInfos': [{'id': '2013-A00065-40', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with adenocarcinoma', 'description': '60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy', 'interventionNames': ['Other: Thrombin Generation Assay']}], 'interventions': [{'name': 'Thrombin Generation Assay', 'type': 'OTHER', 'armGroupLabels': ['Patients with adenocarcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yesim Dargaud, MD, PhD', 'role': 'CONTACT', 'email': 'ydargaud@univ-lyon1.fr', 'phone': '(0)4 72 11 88 25', 'phoneExt': '+33'}, {'name': 'Yesim Dargaud, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Unité d'Hémostase Clinique Hôpital Louis Pradel", 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Yesim DARGAUD, MD PHD', 'role': 'CONTACT', 'email': 'ydargaud@univ-lyon1.fr', 'phone': '(0)4 72 11 88 25', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}