Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-24 @ 6:50 PM
Study NCT ID:
NCT01884168
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2013-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2013-06-19', 'studyFirstSubmitQcDate': '2013-06-19', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunotherapy response', 'timeFrame': '1 month', 'description': 'T-Cell Receptor and B-Cell Receptor gene expression profiling and the change of cytokines, lymphocytes subpopulation before and after DC-CIK infusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor presenting malignant cavity effusion after DC-CIK immunotherapy.', 'detailedDescription': '1. The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.\n2. Malignant cavity effusion from cancer patients is obtained through puncture and is centrifugalized to get supernatant fluid and enrich cancer cells before and after the therapy.\n3. The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.\n4. The T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.\n5. Statistical analysis is performed using unsupervised hierarchical cluster.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The malignant tumor patients present with malignant cavity effusion and can receive DC-CIK immunotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed with malignant tumor and malignant cavity effusion.\n2. An Eastern Cooperative Oncology Group（ECOG）performance status of 0-2.\n3. Normal cardiac, hepatic, renal and bone marrow functions.\n4. Life expectancy \\>3 months.\n5. Not receive other anti-tumor treatment.\n6. Not receive chemotherapy in pleural and abdominal cavity.\n\nExclusion Criteria:\n\n1. Previous history of other malignancies.\n2. Serious or uncontrolled concurrent medical illness.'}, 'identificationModule': {'nctId': 'NCT01884168', 'briefTitle': 'Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy', 'orgStudyIdInfo': {'id': 'GIMCEI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'gene expression profile', 'description': 'T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.', 'interventionNames': ['Biological: Dc-CIK immunotherapy']}], 'interventions': [{'name': 'Dc-CIK immunotherapy', 'type': 'BIOLOGICAL', 'description': 'The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.', 'armGroupLabels': ['gene expression profile']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Capital Medical University Cancer Center/Beijing Shijitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jun Ren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University Cancer Center /Beijing Shijitan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Jun Ren MD, PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}