Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-02-23 @ 10:20 AM
Study NCT ID:
NCT01906632
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2013-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2013-07-21', 'studyFirstSubmitQcDate': '2013-07-21', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T-Cell Receptor/B-Cell Receptor gene expression', 'timeFrame': '3 month'}]}, '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 after DC-CIK immunotherapy.', 'detailedDescription': '1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .\n2. Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing.\n3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。\n4. Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy.\n5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed with malignant tumor;\n* Age: 18-80 years;\n* an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* At least one measurable lesion according to the RECIST criteria;\n* Adequate bone marrow, cardiac, liver, and renal function;\n* Life expectancy ≥2 months;\n* Not received other anti-tumor treatment\n* Informed consent signed\n\nExclusion Criteria:\n\n* previous history of other malignancies;\n* Uncontrolled central nervous system metastases;\n* Serious or uncontrolled concurrent medical illness.'}, 'identificationModule': {'nctId': 'NCT01906632', 'briefTitle': 'Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'orgStudyIdInfo': {'id': 'GIMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'gene expression profile', 'interventionNames': ['Biological: DC-CIK Immunotherapy']}], 'interventions': [{'name': 'DC-CIK Immunotherapy', 'type': 'BIOLOGICAL', 'armGroupLabels': ['gene expression profile']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'country': 'China', 'facility': 'Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Capita Medical University Cancer Center', 'investigatorFullName': 'Jun Ren MD, PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}