Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
Study NCT ID:
NCT06672250
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2024-10-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Correlation Between Circulatory Tumor Cells and Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cell culture', 'timeFrame': 'baseline', 'description': 'cancer-specific surface markers'}, {'measure': 'RNA-seq', 'timeFrame': 'baseline', 'description': "DNA/RNA extraction of sorted cells as instruments' maneuvers and do the RNA-seq"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Thrombosis', 'Venous thromboembolism', 'Circulating tumor cells', 'Endovascular therapy'], 'conditions': ['Tumor Cells, Circulating', 'Venous Thrombosis']}, 'referencesModule': {'references': [{'pmid': '21971578', 'type': 'RESULT', 'citation': 'Falanga A, Russo L. Epidemiology, risk and outcomes of venous thromboembolism in cancer. Hamostaseologie. 2012;32(2):115-25. doi: 10.5482/ha-1170. Epub 2011 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'Research indicates a strong correlation between cancer and thrombosis, with approximately 20% of blood clots in the U.S. being cancer-related, according to CDC data. Cancer patients face a 4-7 times higher risk of thrombosis compared to non-cancer individuals. Certain cancer treatments, such as chemotherapy and targeted therapy, elevate the likelihood of venous thromboembolism (VTE). Cancer patients with VTE exhibit a significantly higher hazard ratio (H.R.) of 3.4 compared to those without VTE.\n\nThis study aims to explore three main topics: (1) Comparing the differences and similarities of leukocyte populations between cancer-associated thrombosis (CAT) and venous thromboembolism (VTE). (2) Characterizing the factors contributing to increased incidence of cancer-associated thrombosis (CAT), with the hypothesis that circulating tumor microemboli (CTM) may express more thrombosis-related proteins than CTCs. (3) Understanding the effects of aspirin or NOACs on cancer-associated thrombosis and CTM formation.', 'detailedDescription': 'Research indicates a strong correlation between cancer and thrombosis, with approximately 20% of blood clots in the U.S. being cancer-related, according to CDC data. Cancer patients face a 4-7 times higher risk of thrombosis compared to non-cancer individuals. Certain cancer treatments, such as chemotherapy and targeted therapy, elevate the likelihood of venous thromboembolism (VTE). Cancer patients with VTE exhibit a significantly higher hazard ratio (H.R.) of 3.4 compared to those without VTE.\n\nThe mechanisms underlying cancer-related thrombosis are intricate. Cancer cells can directly activate coagulation and platelets through various factors, including tissue factor (T.F.), particularly prevalent in specific cancers like pancreatic and ovarian, correlating with a heightened VTE risk and poorer prognosis. Additionally, factors such as podoplanin (PDPN), plasminogen activation inhibitor-1 (PAI-1), and cancer procoagulant (C.P.) further promote coagulation. Inflammatory cytokines originating from tumor cells and cancer-derived factors stimulate neutrophil extracellular traps, contributing to thrombosis.\n\nMetastatic tumors facilitate cancer cell dissemination and entry into blood vessels, leading to thrombosis in certain instances. Analyzing circulating tumor cells (CTCs) from biopsies aids in comprehending cancer metastasis and identifying treatment targets. However, isolating these rare CTCs from blood presents a challenge. Endovascular therapy has made strides in thrombosis treatment, with endovascular thrombectomy showing promise in severe thrombosis cases. It is proposed that aspirating thrombi during this procedure could yield CTCs for further examination regarding the impact of cancer cells on thrombogenesis.\n\nThis study aims to explore three main topics: (1) Comparing the differences and similarities of leukocyte populations between cancer-associated thrombosis (CAT) and venous thromboembolism (VTE). (2) Characterizing the factors contributing to increased incidence of cancer-associated thrombosis (CAT), with the hypothesis that circulating tumor microemboli (CTM) may express more thrombosis-related proteins than CTCs. (3) Understanding the effects of aspirin or NOACs on cancer-associated thrombosis and CTM formation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent catheter-based thrombectomy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ageā§18\n2. participants (1)participants without cancer: without cancer in five years (2)participants with cancer:pathology reveal have malignant tumor\n3. patients who underwent catheter-based thrombectomy\n4. agree do the thrombectomy\n\nExclusion Criteria:\n\n1. participants without cancer (1).shock (2).severe sepsis (3).with cancer in five years\n2. participants with cancer (1).shock (2).severe sepsis'}, 'identificationModule': {'nctId': 'NCT06672250', 'briefTitle': 'The Correlation Between Circulatory Tumor Cells and Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Correlation Between Circulatory Tumor Cells and Venous Thrombosis', 'orgStudyIdInfo': {'id': '202400562B0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cancer for CTC culture', 'description': 'a thrombosis patient with cancer .', 'interventionNames': ['Procedure: CTCs/CTMs culture']}, {'label': 'health for CTC culture', 'description': 'a thrombosis patient without cancer', 'interventionNames': ['Procedure: CTCs/CTMs culture']}], 'interventions': [{'name': 'CTCs/CTMs culture', 'type': 'PROCEDURE', 'description': 'Collect the thrombosis from participants underwent catheter-based thrombectomy.To characterized by cancer-specific surface markers successfully and identify within the culture', 'armGroupLabels': ['cancer for CTC culture', 'health for CTC culture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsin-Fu Lee, PhD', 'role': 'CONTACT'}], 'facility': 'New Taipei City TuCheng Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Hsin-Fu Lee, PhD', 'role': 'CONTACT', 'email': '8805033@cgmh.org.tw', 'phone': '0975366105'}, {'name': 'Chia-Hsun Hsieh, PhD', 'role': 'CONTACT', 'email': 'wisdom5000@cgmh.org.tw', 'phone': '0975366137'}], 'overallOfficials': [{'name': 'Hsin-Fu Lee, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'New Taipei City TuCheng Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Attending Physicians', 'investigatorFullName': 'Hsin-Fu Lee', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}