Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-02 @ 1:16 PM
Study NCT ID:
NCT07142057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study on the Impact of the 23-valent Pneumonia Vaccine on Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lung cancer-related complications', 'timeFrame': '5 years', 'description': 'The incidence of complications related to lung cancer (such as respiratory failure, infection, etc.).'}, {'measure': 'Length of hospital stay', 'timeFrame': '5 years', 'description': 'Record the number of days of hospitalization for patients hospitalized due to lung infection.'}, {'measure': 'Hospitalization rate', 'timeFrame': '5 years', 'description': 'The proportion of patients hospitalized due to pneumonia or other related complications.'}, {'measure': 'Antibiotic usage', 'timeFrame': '5 years', 'description': 'This includes the types, dosages, and durations of antibiotic usage, etc'}, {'measure': 'Quality of life of lung cancer patients', 'timeFrame': '5 years', 'description': 'Specific quality of life assessment scales are used, such as standardized quality of life assessment tools (such as EORTC QLQ-C30) to evaluate the quality of life of patients.'}, {'measure': 'Immune response', 'timeFrame': '5 years', 'description': 'The immune response (such as antibody levels) of patients after vaccination is evaluated through serological testing.'}, {'measure': 'Adverse reactions after vaccination', 'timeFrame': '30 days', 'description': 'Observe whether patients who receive the 23-valent pneumococcal vaccine experience adverse reactions after vaccination, such as fever, redness, swelling and pain at the injection site, headache, dizziness, etc.'}], 'primaryOutcomes': [{'measure': 'The incidence of pneumonia at 12 months', 'timeFrame': '12 months', 'description': 'During the 12-month follow-up period, the incidence of pulmonary infection in lung cancer patients was evaluated through regular clinical examinations, imaging tests, and laboratory tests.'}, {'measure': 'Incidence of pneumonia', 'timeFrame': '24 months', 'description': 'The proportion of lung cancer patients who developed pneumonia during the study period.'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '5 years', 'description': 'The survival rate of lung cancer patients within a specific time period (such as 1 year, 2 years, or 5 years).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['LUNG CANCER']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of the 23-valent pneumonia vaccine on the incidence of pulmonary infection and survival in lung cancer patients, and to explore its preventive effect and safety in the lung cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients can receive or not receive the 23-valent pneumococcal vaccine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients \\>=18 years of age;\n2. Histological diagnosis of NSCLC, including both non-small cell lung cancer and small cell lung cancer, regardless of whether they are in the early, locally advanced stage or advanced stage, and regardless of whether they have received surgery, radiotherapy, chemotherapy or other treatments;\n3. Never received pneumococcal vaccine\n\nExclusion Criteria:\n\nPatients having other factors that preventing researchers from enrollment them.'}, 'identificationModule': {'nctId': 'NCT07142057', 'briefTitle': 'An Observational Study on the Impact of the 23-valent Pneumonia Vaccine on Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'An Observational Study on the Impact of the 23-valent Pneumonia Vaccine on the Incidence of Pulmonary Infection and Survival in Lung Cancer Patients', 'orgStudyIdInfo': {'id': '23V-PNEUMO-LC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccination group', 'description': 'Lung cancer patients receive 23-valent pneumonia vaccine', 'interventionNames': ['Biological: 23-valent pneumococcal vaccine']}, {'label': 'Unvaccinated group', 'description': 'Lung cancer patients have not received the 23-valent pneumococcal vaccine'}], 'interventions': [{'name': '23-valent pneumococcal vaccine', 'type': 'BIOLOGICAL', 'description': 'Receive the 23-valent pneumococcal vaccine; Do not receive the 23-valent pneumococcal vaccine', 'armGroupLabels': ['Vaccination group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The First Affiliated Hospital of Guangzhou Medical University', 'investigatorFullName': 'Yalei Zhang', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}