Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT07170059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on the Impact of Herpes Zoster Vaccine on the Incidence of Herpes Zoster and Survival in 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': 'D053061', 'term': 'Herpes Zoster Vaccine'}], 'ancestors': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-07', 'studyFirstSubmitDate': '2025-09-07', 'studyFirstSubmitQcDate': '2025-09-07', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lung cancer-related complications', 'timeFrame': '5 years', 'description': 'Severity of herpes zoster and incidence of complications (e.g., postherpetic neuralgia)'}, {'measure': 'Length of hospital stay', 'timeFrame': '5 years', 'description': 'Record the number of days of hospitalization for patients hospitalized due to herpes zoster'}, {'measure': 'Hospitalization rate', 'timeFrame': '5 years', 'description': 'The proportion of patients hospitalized due to herpes zoster or other related complications.'}, {'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 herpes zoster 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 herpes zoster at 12 months', 'timeFrame': '12 months', 'description': 'During the 12-month follow-up period, the incidence of herpes zoster in lung cancer patients was evaluated through regular clinical examinations, imaging tests, and laboratory tests.'}, {'measure': 'Incidence of herpes zoster', 'timeFrame': '24 months', 'description': 'The proportion of lung cancer patients who developed herpes zoster 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': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of herpes zoster vaccine on the incidence of herpes zoster and survival in lung cancer patients, and to explore its preventive effect and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients can receive or not receive the herpes zoster vaccine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Male or female patients \\>=18 years of age; 2.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; 3. Never received herpes zoster vaccine\n\nExclusion Criteria:\n\n* Patients having other factors that preventing researchers from enrollment them.'}, 'identificationModule': {'nctId': 'NCT07170059', 'briefTitle': 'Observational Study on the Impact of Herpes Zoster Vaccine on the Incidence of Herpes Zoster and Survival in Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'An Observational Study on the Impact of Herpes Zoster Vaccine on the Incidence of Herpes Zoster and Survival in Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'ZSHV-LC-OBS2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccination group', 'description': 'Lung cancer patients receive herpes zoster vaccine', 'interventionNames': ['Biological: herpes zoster vaccine']}, {'label': 'Unvaccinated group', 'description': 'Lung cancer patients have not received herpes zoster vaccine'}], 'interventions': [{'name': 'herpes zoster vaccine', 'type': 'BIOLOGICAL', 'description': 'Receive the herpes zoster vaccine; Do not receive the herpes zoster 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'}}}}