Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 6:10 AM
Study NCT ID:
NCT06202534
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2024-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-01', 'studyFirstSubmitDate': '2024-01-01', 'studyFirstSubmitQcDate': '2024-01-01', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erythroid precursor cells increase after radiotherapy.', 'timeFrame': 'Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.', 'description': 'Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.'}], 'secondaryOutcomes': [{'measure': 'Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.', 'timeFrame': 'Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.Peripheral blood myeloid-derived suppressor cells (MDSCs) gradually decreased to the pre-radiation level after 3 months of radiotherapy.', 'description': 'Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.Peripheral blood myeloid-derived suppressor cells (MDSCs) gradually decreased to the pre-radiation level after 3 months of radiotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erythroid Precursor Cells'], 'conditions': ['Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'To explore the impact of radiotherapy on peripheral blood myeloid-derived suppressor cells (MDSCs), T cells and extramedullary erythroid precursor cells in patients with malignant tumors, and to evaluate the correlation between changes in the proportion of these cells before and after radiotherapy and the efficacy of radiotherapy in patients.', 'detailedDescription': 'To clarify the impact of radiotherapy (and/or other treatment combinations) on the proportion of myeloid-derived suppressor cells (MDSCs), T cells and extramedullary erythroid precursor cells in the peripheral blood of patients with malignant tumors, and to evaluate the changes in the proportion of these cells before and after radiotherapy and the relationship between the patients Correlation with the efficacy of radiotherapy. On this basis, it provides theoretical guidance for the determination of new clinical treatment plans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Over 18 years old, diagnosed with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, head and neck cancer and requiring radiotherapy, and the above malignant tumors have not metastasized.\n2. Complete inspection information.\n3. No other serious complications.\n4. No infectious diseases.\n5. Able and willing to take blood tests.\n6. All researchers gave informed consent and signed an informed consent form, which complied with the requirements of the Medical Ethics Committee.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 18 years old, diagnosed with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, head and neck cancer and requiring radiotherapy, and the above malignant tumors have not metastasized.\n2. Complete inspection information.\n3. No other serious complications.\n4. No infectious diseases.\n5. Able and willing to take blood tests.\n6. All researchers gave informed consent and signed an informed consent form, which complied with the requirements of the Medical Ethics Committee.\n\nExclusion Criteria:\n\n1. People with mental illness.\n2. People with autoimmune system diseases.\n3. Those combined with serious diseases of other organs.\n4. Those with severe alcoholism and drug abuse.\n5. Research subjects who voluntarily withdraw from the study.'}, 'identificationModule': {'nctId': 'NCT06202534', 'briefTitle': 'An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou First People's Hospital"}, 'officialTitle': 'An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.', 'orgStudyIdInfo': {'id': 'K-2023-093-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before radiotherapy,', 'description': 'Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients before radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells.'}, {'label': 'During radiotherapy', 'description': 'Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients during radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells.'}, {'label': 'After radiotherapy', 'description': 'Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients after radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells.'}, {'label': '3 months after radiotherapy', 'description': 'Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients 3 months after radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells.'}], 'interventions': [{'type': 'OTHER', 'description': 'radiotherapy', 'armGroupLabels': ['3 months after radiotherapy', 'After radiotherapy', 'Before radiotherapy,', 'During radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yong wu, PhD', 'role': 'CONTACT', 'email': 'eywuyong@scut.edu.cn', 'phone': '86-13640836938'}], 'facility': 'GuangzhouFPH', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'yong wu, PhD', 'role': 'CONTACT', 'email': 'eywuyong@scut.edu.cn', 'phone': '86-13640836938'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.', 'investigatorFullName': 'Yong Wu', 'investigatorAffiliation': "Guangzhou First People's Hospital"}}}}