Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 3:51 AM
Study NCT ID:
NCT06727669
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Cohort of Thrombosis and Hemostasis Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D011697', 'term': 'Purpura, Thrombotic Thrombocytopenic'}, {'id': 'C536392', 'term': 'Factor 8 deficiency, acquired'}, {'id': 'D004211', 'term': 'Disseminated Intravascular Coagulation'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'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'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prognosis', 'timeFrame': '5 years', 'description': 'To analyze the long-term prognosis of patients with thrombosis and hemostasis diseases, such as immune thrombocytopenia (ITP),thrombotic thrombocytopenic purpura, hereditary and acquired hemophilia, disseminated intravascular coagulation, pregnancy With ITP, pregnancy With prethrombotic state (such as protein C, protein S deficiency, etc.), deep vein thrombosis, pulmonary embolism, thrombotic microangiopathies, thrombocytopenia or coagulation abnormalities after hematopoietic stem cell transplantation, hereditary and acquired thrombophilia, platelet dysfunction,arterial thromboembolism, and hereditary hemorrhagic disease , et al., and analyze the risk factors associated with their prognosis.'}], 'secondaryOutcomes': [{'measure': 'Incidence', 'timeFrame': '5 years', 'description': 'To describe the incidence of thrombosis and hemostasis diseases, and analyze the risk factors associated with these diseases.'}, {'measure': 'Distribution', 'timeFrame': '5 years', 'description': 'The population characteristics of thrombosis and hemostasis diseases'}, {'measure': 'Overall response rate', 'timeFrame': '180 days', 'description': 'To analyze the therapeutic efficacy of patients with thrombosis and hemostasis diseases, and analyze the impact factors associated with the efficacy.'}, {'measure': 'Long-term overall remission rate', 'timeFrame': '1 years', 'description': 'Proportion of the participants with an overall remission.'}, {'measure': 'Safety of treatment', 'timeFrame': '1 years', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.'}, {'measure': 'Health economic evaluation', 'timeFrame': '5 years', 'description': 'To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombosis', 'Hemostasis'], 'conditions': ['Immune Thrombocytopenia', 'Thrombotic Thrombocytopenic Purpura', 'Hemophilia A, Acquired', 'Disseminated Intravascular Coagulation', 'Thrombophilia', 'Deep Vein Thrombosis', 'Pulmonary Embolism', 'Thrombotic Microangiopathies', 'Coagulation Factor Deficiency', 'Hemophilia A', 'Hemophilia B', 'Hemophilia B, Acquired', 'Platelet Dysfunction', 'Arterial Thromboembolism', 'Bleeding Disorder', 'Thrombosis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, prospective, longitudinal, observational cohort study to investigate thrombosis and hemostasis diseases in Chinese patients. This study will collect basic information, diagnostic and treatment information, as well as medical expense information of patients from medical records.The incidence and risk factors of thrombosis and hemostasis diseases, the treatment methods, prognosis and medical expenses of these patients in China will be analyzed. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.', 'detailedDescription': "Thrombosis and hemostasis diseases are a group of high-risk hematological diseases, characterized by bleeding or hypercoagulability caused by congenital or acquired abnormalities in hemostasis, coagulation, and fibrinolysis. Thrombosis and hemostasis diseases included various bleeding and thrombotic diseases such as primary immune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP), hemophilia, disseminated intravascular coagulation (DIC), thrombophilia, pregnancy with ITP, pregnancy with prethrombotic state (such as protein C, protein S deficiency, etc.), deep vein thrombosis, pulmonary embolism, thrombocytopenia and coagulation abnormalities after hematopoietic stem cell transplantation, and so on. Thrombosis and hemostasis diseases have a high incidence rate, may affect patients' quality of life and even are associated with the poor survival. However, current studies are mostly based on data from limited sample size cohorts, lacking comprehensive and large-scale prospective cohort studies.\n\nThis is a multicenter, prospective, longitudinal, observational cohort study investigating the incidence and risk factors of thrombosis and hemostasis diseases, and to analyze the treatment methods, prognosis and medical expenses of these patients in China.This study will collect basic information, diagnostic and treatment information, as well as medical expense information of patients from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were diagnosed as thrombosis and hemostasis diseases, including immune thrombocytopenia, thrombotic thrombocytopenic purpura, hereditary and acquired Hemophilia, disseminated intravascular coagulation, pregnancy With ITP, pregnancy With prethrombotic state (such as protein C, protein S deficiency, etc.), deep vein thrombosis, pulmonary embolism, thrombocytopenia and coagulation abnormalities after hematopoietic stem cell transplantation, hereditary and acquired thrombophilia,hereditary hemorrhagic disease , et al.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who were diagnosed as thrombosis and hemostasis diseases.\n\nExclusion Criteria:\n\n* Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.\n* Patients with alcohol and drug addictions or mental illness affect their ability to comply with study requirements.\n* According to the investigator, there are conditions that may endanger the patient's safety or affect his/her compliance."}, 'identificationModule': {'nctId': 'NCT06727669', 'briefTitle': 'Longitudinal Cohort of Thrombosis and Hemostasis Diseases', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Longitudinal Cohort of Thrombosis and Hemostasis Diseases', 'orgStudyIdInfo': {'id': '2024PHB401-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Hui Zhang, MD', 'role': 'CONTACT', 'email': 'zhangxh100@sina.com'}, {'name': 'Haixia Fu, MD', 'role': 'CONTACT', 'email': 'fuhaixia_210@163.com', 'phone': '086-01088326002'}, {'name': 'Xiaohui Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Peking University Insititute of Hematology, Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhao Wang', 'role': 'CONTACT'}], 'facility': 'Department of Hematology, Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Liu', 'role': 'CONTACT'}], 'facility': 'Department of Hematology, Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongxing Jiang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Chongqing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Zhang', 'role': 'CONTACT'}], 'facility': 'Xinqiao Hospital, Army Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Haixia Fu, MD', 'role': 'CONTACT', 'email': 'fuhaixia_210@163.com', 'phone': '086-01088326002'}, {'name': 'Zhuoyu An', 'role': 'CONTACT', 'phone': '086-01088326001'}], 'overallOfficials': [{'name': 'Xiao-Hui Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University Institute of Hematology, Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital", 'investigatorFullName': 'Xiao Hui Zhang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}