Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-25 @ 3:55 PM
Study NCT ID:
NCT03471468
Status:
TERMINATED
Last Update Posted:
2020-02-17
First Post:
2018-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Low recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2018-03-13', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France)', 'timeFrame': 'Before chemotherapies #1 to #6'}, {'measure': 'Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France)', 'timeFrame': 'After 6 hours of chemotherapies #1 to #6'}], 'secondaryOutcomes': [{'measure': 'incidence of thrombosis during study', 'timeFrame': 'Before chemotherapies #1 to #6 and one year after inclusion.', 'description': 'Deep vein thrombosis or pulmonary embolism'}, {'measure': 'Khorana score does assess the risk of thrombosis uner chemotherapy according to 3 levels :Score 0, 1, 2 or 3', 'timeFrame': 'Before chemotherapies #1 to #6', 'description': 'Score 0= low risk (incidence of thrombosis = 0.3%) Score 1 or 2= intermediate risk (incidence of thrombosis = 2%) Score \\>3 = high risk (incidence of thrombosis = 6.7%) The highest possible score is 6.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microparticles', 'Pancreatic cancer', 'Gastric cancer', 'Chemotherapy', 'Venous thromboembolism'], 'conditions': ['Pancreatic Cancer', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Microparticles have recently emerged as a thrombotic risk marker with a potential role in determining which patients are at greatest risk for developing thrombosis. Available data show an increase in the level of microparticles in cancer patients who are undergoing chemotherapy for solid tumors with a possible link to their thrombogenic state.\n\nOur study focuses on the kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity.\n\nDetailed Description:\n\nThe impact of chemotherapy on microparticles expression will be assessed by measuring their procoagulant activity on blood samples taken during the course of chemotherapy. The thrombotic risk will be evaluated by the score of Khorana in parallel. Microparticles expression in patients with thrombosis will be compared to that in other patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-line chemotherapy indicated and accepted by the patient for pancreatic cancer or gastric cancer\n* Confirmed diagnosis of pancreatic cancer or gastric cancer\n* Free subject, without guardianship or trusteeship or subordination\n* Patient benefiting from a social security scheme or benefiting through a third party\n* Consent given by the patient after clear and fair information about the study\n\nExclusion Criteria:\n\n* Age \\< 18yo\n* Life expectancy ≤10days\n* Deep vein thrombosis ou pulmonary embolism ≤3months\n* Patient unable to receive chemotherapy (sepsis, acute coronary syndrome, recent stroke, heparin-induced thrombocytopenia, disseminated intravascular coagulation)\n* Person enjoying enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situations\n* Pregnant or lactating woman and woman of childbearing age lacking effective contraception'}, 'identificationModule': {'nctId': 'NCT03471468', 'acronym': 'DOMICA', 'briefTitle': 'Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Study of the Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'DOMICA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'kinetics of microparticles under chemotherapy', 'description': 'kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity.', 'interventionNames': ['Procedure: kinetics of microparticles under chemotherapy']}], 'interventions': [{'name': 'kinetics of microparticles under chemotherapy', 'type': 'PROCEDURE', 'description': 'Blood samples done before chemotherapy and 6 hours later for each of six chemotherapies required by the protocol.', 'armGroupLabels': ['kinetics of microparticles under chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU of Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}